NDC 60505-0829Prescription (Rx only)FDA ANDA · ANDA077538

Fluticasone Propionate

Active substance: Fluticasone Propionate

50 formulations • 78 package configurations

All 128 registered NDCs — click to copy

In one line

Fluticasone Propionate (Fluticasone Propionate) NDC 60505-0829 converts to 60505-0829-01 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence

Listing: 60505-0829 Verified

1. Initial Approval

2007

First U.S. FDA clearance for Fluticasone Propionate

2. FDA Application

ANDA077538

Regulatory pathway: ANDA

3. Market Entry Date

Sep 19, 2007

First commercial NDC distribution & launch date

4. Regulatory Status

Active Commercial Listing

Registration valid through Dec 31, 2027

Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel

NDC direct

Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).

Standard pharmacy claim — no J-Code required

11-digit HIPAA NDC

60505-0829-01

Zero-padded 5-4-2 format

Standard conversion

CPT administration code

Self-Administered (Oral)

Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.

UB-04 revenue code

Rev 0250

0250 (General Pharmacy)

Qualifier: UN

Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.

Every registered strength and package for Fluticasone Propionate, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
50 ug/1	30142-258-01	30142-258	30142-0258-01	1 BOTTLE, SPRAY in 1 CARTON (30142-258-01) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY (30142-258-04)
Inner component	30142-258-04	30142-258	30142-0258-04	Inner component of kit (30142-258-01)
50 ug/1	30142-258-02	30142-258	30142-0258-02	2 BOTTLE, SPRAY in 1 CARTON (30142-258-02) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	30142-258-03	30142-258	30142-0258-03	1 BOTTLE, SPRAY in 1 CARTON (30142-258-03) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY (30142-258-05)
Inner component	30142-258-05	30142-258	30142-0258-05	Inner component of kit (30142-258-03)
50 ug/1	37835-997-31	37835-997	37835-0997-31	1 BOTTLE, SPRAY in 1 CARTON (37835-997-31) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	37835-997-44	37835-997	37835-0997-44	1 BOTTLE, SPRAY in 1 CARTON (37835-997-44) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY
137 ug/1, 50 ug/1	45802-066-01	45802-066	45802-0066-01	1 BOTTLE in 1 CARTON (45802-066-01) / 120 SPRAY, METERED in 1 BOTTLE
50 ug/1	68788-9678-1	68788-9678	68788-9678-01	1 BOTTLE, SPRAY in 1 CARTON (68788-9678-1) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	76420-903-01	76420-903	76420-0903-01	1 BOTTLE, SPRAY in 1 CARTON (76420-903-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	55681-389-14	55681-389	55681-0389-14	1 BOTTLE, SPRAY in 1 CARTON (55681-389-14) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	70518-1655-0	70518-1655	70518-1655-00	1 BOTTLE, SPRAY in 1 CARTON (70518-1655-0) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	68462-918-20	68462-918	68462-0918-20	1 BOTTLE, GLASS in 1 CARTON (68462-918-20) / 120 SPRAY, METERED in 1 BOTTLE, GLASS
50 ug/1	68462-918-44	68462-918	68462-0918-44	1 BOTTLE, GLASS in 1 CARTON (68462-918-44) / 144 SPRAY, METERED in 1 BOTTLE, GLASS
50 ug/1	68462-918-60	68462-918	68462-0918-60	1 BOTTLE, GLASS in 1 CARTON (68462-918-60) / 60 SPRAY, METERED in 1 BOTTLE, GLASS
50 ug/1	68462-918-72	68462-918	68462-0918-72	1 BOTTLE, GLASS in 1 CARTON (68462-918-72) / 72 SPRAY, METERED in 1 BOTTLE, GLASS
50 ug/1	68788-4120-1	68788-4120	68788-4120-01	1 BOTTLE, SPRAY in 1 CARTON (68788-4120-1) / 120 SPRAY in 1 BOTTLE, SPRAY
44 ug/1	68462-937-20	68462-937	68462-0937-20	1 INHALER in 1 CARTON (68462-937-20) / 120 AEROSOL, METERED in 1 INHALER
50 ug/1, 100 ug/1	70518-4406-0	70518-4406	70518-4406-00	1 POUCH in 1 CARTON (70518-4406-0) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER
50 ug/1	72888-141-35	72888-141	72888-0141-35	1 BOTTLE, SPRAY in 1 CARTON (72888-141-35) / 120 SPRAY in 1 BOTTLE, SPRAY
.5 mg/g	0713-0631-15	0713-0631	00713-0631-15	1 TUBE in 1 CARTON (0713-0631-15) / 15 g in 1 TUBE
.5 mg/g	0713-0631-31	0713-0631	00713-0631-31	1 TUBE in 1 CARTON (0713-0631-31) / 30 g in 1 TUBE
.5 mg/g	0713-0631-60	0713-0631	00713-0631-60	1 TUBE in 1 CARTON (0713-0631-60) / 60 g in 1 TUBE
50 ug/1, 100 ug/1	68788-8704-6	68788-8704	68788-8704-06	1 POUCH in 1 CARTON (68788-8704-6) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER
250 ug/1, 50 ug/1	71205-262-60	71205-262	71205-0262-60	1 INHALER in 1 CARTON (71205-262-60) / 60 POWDER in 1 INHALER
.05 mg/g	0713-0632-15	0713-0632	00713-0632-15	1 TUBE in 1 CARTON (0713-0632-15) / 15 g in 1 TUBE
.05 mg/g	0713-0632-31	0713-0632	00713-0632-31	1 TUBE in 1 CARTON (0713-0632-31) / 30 g in 1 TUBE
.05 mg/g	0713-0632-60	0713-0632	00713-0632-60	1 TUBE in 1 CARTON (0713-0632-60) / 60 g in 1 TUBE
50 ug/1	59726-350-38	59726-350	59726-0350-38	1 BOTTLE, SPRAY in 1 CARTON (59726-350-38) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	59726-350-54	59726-350	59726-0350-54	1 BOTTLE, SPRAY in 1 CARTON (59726-350-54) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	42681-0058-1	42681-0058	42681-0058-01	1 BOTTLE in 1 CARTON (42681-0058-1) / 60 SPRAY, METERED in 1 BOTTLE
50 ug/1	68196-210-02	68196-210	68196-0210-02	144 SPRAY, METERED in 1 BOTTLE, SPRAY (68196-210-02)
.05 mg/g	45802-221-11	45802-221	45802-0221-11	1 TUBE in 1 CARTON (45802-221-11) / 30 g in 1 TUBE
.05 mg/g	45802-221-35	45802-221	45802-0221-35	1 TUBE in 1 CARTON (45802-221-35) / 15 g in 1 TUBE
.05 mg/g	45802-221-37	45802-221	45802-0221-37	1 TUBE in 1 CARTON (45802-221-37) / 60 g in 1 TUBE
50 ug/1	51407-871-12	51407-871	51407-0871-12	1 BOTTLE, GLASS in 1 CARTON (51407-871-12) / 120 SPRAY, METERED in 1 BOTTLE, GLASS
.5 mg/g	45802-222-11	45802-222	45802-0222-11	1 TUBE in 1 CARTON (45802-222-11) / 30 g in 1 TUBE
.5 mg/g	45802-222-35	45802-222	45802-0222-35	1 TUBE in 1 CARTON (45802-222-35) / 15 g in 1 TUBE
.5 mg/g	45802-222-37	45802-222	45802-0222-37	1 TUBE in 1 CARTON (45802-222-37) / 60 g in 1 TUBE
100 ug/1, 50 ug/1	66993-584-97	66993-584	66993-0584-97	1 INHALER in 1 CARTON (66993-584-97) / 60 POWDER in 1 INHALER
250 ug/1, 50 ug/1	66993-585-97	66993-585	66993-0585-97	1 INHALER in 1 CARTON (66993-585-97) / 60 POWDER in 1 INHALER
500 ug/1, 50 ug/1	66993-586-97	66993-586	66993-0586-97	1 INHALER in 1 CARTON (66993-586-97) / 60 POWDER in 1 INHALER
50 ug/1	83324-294-01	83324-294	83324-0294-01	1 BOTTLE, SPRAY in 1 CARTON (83324-294-01) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	68196-503-01	68196-503	68196-0503-01	1 BOTTLE, SPRAY in 1 CARTON (68196-503-01) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY (68196-503-02)
Inner component	68196-503-02	68196-503	68196-0503-02	Inner component of kit (68196-503-01)
50 ug/1	73581-510-01	73581-510	73581-0510-01	1 BOTTLE in 1 CARTON (73581-510-01) / 144 SPRAY, METERED in 1 BOTTLE
50 ug/1	73581-510-03	73581-510	73581-0510-03	3 BOTTLE in 1 CARTON (73581-510-03) / 144 SPRAY, METERED in 1 BOTTLE
.5 mg/mL	68462-427-02	68462-427	68462-0427-02	1 BOTTLE in 1 CARTON (68462-427-02) / 60 mL in 1 BOTTLE
50 ug/1	68788-8446-1	68788-8446	68788-8446-01	1 BOTTLE, GLASS in 1 CARTON (68788-8446-1) / 120 SPRAY, METERED in 1 BOTTLE, GLASS
50 ug/1, 250 ug/1	0054-0327-56	0054-0327	00054-0327-56	1 POUCH in 1 CARTON (0054-0327-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER
50 ug/1	73581-530-01	73581-530	73581-0530-01	1 BOTTLE in 1 CARTON (73581-530-01) / 144 SPRAY, METERED in 1 BOTTLE
50 ug/1	73581-530-03	73581-530	73581-0530-03	3 BOTTLE in 1 CARTON (73581-530-03) / 144 SPRAY, METERED in 1 BOTTLE
50 ug/1	36800-222-01	36800-222	36800-0222-01	1 BOTTLE in 1 CARTON (36800-222-01) / 120 SPRAY, METERED in 1 BOTTLE
50 ug/1	36800-222-03	36800-222	36800-0222-03	2 BOTTLE in 1 CARTON (36800-222-03) / 120 SPRAY, METERED in 1 BOTTLE
50 ug/1	36800-222-09	36800-222	36800-0222-09	1 BOTTLE in 1 CARTON (36800-222-09) / 144 SPRAY, METERED in 1 BOTTLE
50 ug/1	36800-222-10	36800-222	36800-0222-10	2 BOTTLE in 1 CARTON (36800-222-10) / 144 SPRAY, METERED in 1 BOTTLE
50 ug/1	66993-790-97	66993-790	66993-0790-97	1 INHALER in 1 CARTON (66993-790-97) / 60 POWDER, METERED in 1 INHALER
50 ug/1	60505-0829-1	60505-0829	60505-0829-01	1 BOTTLE, SPRAY in 1 CARTON (60505-0829-1) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
100 ug/1	66993-791-97	66993-791	66993-0791-97	1 INHALER in 1 CARTON (66993-791-97) / 60 POWDER, METERED in 1 INHALER
50 ug/1, 250 ug/1	68788-8453-6	68788-8453	68788-8453-06	1 POUCH in 1 CARTON (68788-8453-6) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER
250 ug/1	66993-792-97	66993-792	66993-0792-97	1 INHALER in 1 CARTON (66993-792-97) / 60 POWDER, METERED in 1 INHALER
137 ug/1, 50 ug/1	60505-0953-3	60505-0953	60505-0953-03	1 BOTTLE, SPRAY in 1 CARTON (60505-0953-3) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	72189-004-01	72189-004	72189-0004-01	1 SPRAY, METERED in 1 BOTTLE, SPRAY (72189-004-01)
50 ug/1	60505-0955-1	60505-0955	60505-0955-01	1 BOTTLE, SPRAY in 1 CARTON (60505-0955-1) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	60505-0955-3	60505-0955	60505-0955-03	3 BOTTLE, SPRAY in 1 CARTON (60505-0955-3) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
50 ug/1	60505-6205-3	60505-6205	60505-6205-03	1 BOTTLE, SPRAY in 1 CARTON (60505-6205-3) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
.5 mg/g	63187-959-15	63187-959	63187-0959-15	15 g in 1 TUBE (63187-959-15)
.5 mg/g	63187-959-30	63187-959	63187-0959-30	30 g in 1 TUBE (63187-959-30)
.5 mg/g	63187-959-60	63187-959	63187-0959-60	60 g in 1 TUBE (63187-959-60)
.5 mg/mL	45802-441-02	45802-441	45802-0441-02	60 mL in 1 BOTTLE (45802-441-02)
44 ug/1	68788-8762-1	68788-8762	68788-8762-01	1 INHALER in 1 CARTON (68788-8762-1) / 120 AEROSOL, METERED in 1 INHALER
50 ug/1	0054-3270-99	0054-3270	00054-3270-99	1 BOTTLE, GLASS in 1 CARTON (0054-3270-99) / 120 SPRAY, METERED in 1 BOTTLE, GLASS
50 ug/1	49035-362-05	49035-362	49035-0362-05	1 BOTTLE, SPRAY in 1 CARTON (49035-362-05) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY
113 ug/1, 14 ug/1	63629-8809-1	63629-8809	63629-8809-01	1 POUCH in 1 CARTON (63629-8809-1) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
.5 mg/g	0168-0332-15	0168-0332	00168-0332-15	15 g in 1 TUBE (0168-0332-15)
.5 mg/g	0168-0332-30	0168-0332	00168-0332-30	30 g in 1 TUBE (0168-0332-30)
.5 mg/g	0168-0332-60	0168-0332	00168-0332-60	60 g in 1 TUBE (0168-0332-60)
232 ug/1, 14 ug/1	63629-8810-1	63629-8810	63629-8810-01	1 POUCH in 1 CARTON (63629-8810-1) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections

INDICATIONS AND USAGE

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion itchy, watery eyes itchy nose runny nose sneezing

DOSAGE AND ADMINISTRATION

Directions read the Quick Start Guide for how to: prime the bottle use the spray clean the spray nozzle shake gently before each use use this product only once a day do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER Week 1- use 2 sprays in each nostril once daily Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms After 6 months of daily use – ask your doctor if you can keep using CHILDREN 4 TO 11 YEARS OF AGE the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. an adult should supervise use use 1 spray in each nostril once daily CHILDREN UNDER 4 YEARS OF AGE do not use

WARNINGS AND PRECAUTIONS

Warnings Only for use in the nose. Do not spray into your eyes or mouth.

Pharmacologic class

Corticosteroid Hormone Receptor Agonists

Every other National Drug Code registered in the same established class.

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Corticosteroid Hormone Receptor Agonists