Prescription drug · ANDA
Fluticasone Propionate NDC 0168-0332
Fluticasone propionate .5 mg/g · Cream · Topical · E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0332-15 | 0016803321500168033215 | 15 g in 1 TUBE (0168-0332-15)Marketed from May 14, 2004 | |
| 0168-0332-30 | 0016803323000168033230 | 30 g in 1 TUBE (0168-0332-30)Marketed from May 14, 2004 | |
| 0168-0332-60 | 0016803326000168033260 | 60 g in 1 TUBE (0168-0332-60)Marketed from May 14, 2004 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fluticasone Propionate
- Generic name (nonproprietary)
- fluticasone propionate
- Active ingredients
- Fluticasone propionate — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.NDC labeler code 0168
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076451
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0168-0332_c1a3e651-d30b-49d5-8c5b-77a07006194fSPL ID c1a3e651-d30b-49d5-8c5b-77a07006194fSPL set ID 0e20d1cc-5c7a-4e0d-810b-b94c4d6dd1c0RxCUI 895987UNII O2GMZ0LF5WUPC 0301680332154
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400168033215followed by a unit qualifier and the quantityPackage 00168-0332-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.
Excerpt only. Read the full label for complete information.
About NDC 0168-0332
- What is NDC 0168-0332?
- 0168-0332 is the product NDC for Fluticasone Propionate, Fluticasone propionate .5 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluticasone Propionate.
- What is the active ingredient?
- Fluticasone propionate.
- Who is the labeler?
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., NDC labeler code 0168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluticasone Propionate?
- 61 other product NDCs are listed under this name. See all Fluticasone Propionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluticasone Propionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | YYBA Corp | 73581-510 | 73581-0510-0173581-0510-03 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Glenmark Pharmaceuticals Inc., USA | 68462-918 | 68462-0918-2068462-0918-4468462-0918-60+1 more |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-350 | 59726-0350-3859726-0350-54 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Chain Drug Marketing Association, Inc. | 83324-294 | 83324-0294-01 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Family Dollar Stores, LLC | 55319-058 | 55319-0058-01 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | SprayNasal | Preferred Pharmaceuticals Inc. | 68788-4120 | 68788-4120-01 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-014 | 69168-0014-01 |
| Fluticasone Propionate | Fluticasone propionate 44 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Glenmark Pharmaceuticals Inc., USA | 68462-937 | 68462-0937-20 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Grocery Outlet | 85828-448 | 85828-0448-01 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | IPG Pharmaceuticals, Inc. | 71085-090 | 71085-0090-1671085-0090-32 |
Other NDCs under ANDA 076451
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluticasone Propionate | Fluticasone propionate .5 mg/g | CreamTopical | Proficient Rx LP | 63187-959 |