Over-the-counter drug · ANDA
Allergy Relief (Fexofenadine hcl) NDC 69168-416
Fexofenadine hydrochloride 180 mg/1 · Capsule, Coated · Oral · Allegiant Health
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69168-416Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0416Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-416-03 | 69168041603 | 3 CAPSULE, COATED in 1 CARTON (69168-416-03)Marketed from Aug 14, 2020 | |
| 69168-416-06 | 69168041606 | 120 CAPSULE, COATED in 1 BOTTLE, PLASTIC (69168-416-06)Marketed from Aug 14, 2020 | |
| 69168-416-30 | 69168041630 | 30 CAPSULE, COATED in 1 BOTTLE (69168-416-30)Marketed from Aug 14, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Allergy Relief
- Generic name (nonproprietary)
- fexofenadine hcl
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1
- Dosage form
- Capsule, Coated
- Route
- Oral
- Labeler
- Allegiant HealthNDC labeler code 69168
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204507
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69168-416_054a111e-78f9-453f-8ee2-c54d64c116e4SPL ID 054a111e-78f9-453f-8ee2-c54d64c116e4SPL set ID 61eebc8a-8d1e-48a2-afb1-eda9cb00ff97UNII 2S068B75ZU
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469168041603followed by a unit qualifier and the quantityPackage 69168-0416-03. 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)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 69168-416
- What is NDC 69168-416?
- 69168-416 is the product NDC for Allergy Relief (fexofenadine hcl), Fexofenadine hydrochloride 180 mg/1 capsule, coated, listed with the FDA by Allegiant Health. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allergy Relief (Fexofenadine HCl).
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allergy Relief?
- 262 other product NDCs are listed under this name. See all Allergy Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Allergy Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Famora Inc. | 87509-0003 | 87509-0003-06 |
| Allergy Relieflevocetirizine dihydrochloride usp, 5 mg | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Topco Associates, LLC | 76162-915 | 76162-0915-3576162-0915-80 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-391 | 72288-0391-0172288-0391-78 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0771 | 70000-0771-0170000-0771-02 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-784 | 72288-0784-27 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer, Inc. | 79481-9723 | 79481-9723-01 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-434 | 75907-0434-0175907-0434-30 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | Kroger Company | 30142-856 | 30142-0856-62 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-040 | 84324-0040-01 |
| Allergy Reliefcetirizine tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | DISCOUNT DRUG MART, INC | 53943-130 | 53943-0130-1353943-0130-17 |
Other NDCs under ANDA 204507
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 |
|---|---|---|---|---|
| Gencare-Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-068 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2165 |
| Fexofenadine Hydrochloridefexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-231 |
| Allergy Relief non drowsyfexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | MEIJER, INC. | 41250-506 |
| Curist Allergy Relieffexofenadine hydrochloride 180 mg | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Little Pharma, Inc. | 72559-027 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | NUVICARE LLC | 84324-045 |
| Curist Hives Relieffexofenadine hydrochloride 180 mg | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Little Pharma, Inc. | 72559-028 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Akron Pharma Inc. | 71399-8042 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | AKRON PHARMA INC | 71399-8659 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-893 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Magno-Humphries, Inc. | 54257-170 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-905 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7192 |
| Fexofenadine HCl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Camber Consumer Care | 69230-201 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Camber Consumer Care | 69230-202 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA CORP | 73581-011 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-701 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA CORP | 73581-103 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-801 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7486 |
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