Over-the-counter drug · ANDA
fexofenadine hcl NDC 71335-2165
Fexofenadine hydrochloride 60 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2165-1 | 71335216501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1)Marketed from Sep 6, 2024 | |
| 71335-2165-2 | 71335216502 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2)Marketed from Aug 25, 2022 | |
| 71335-2165-3 | 71335216503 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3)Marketed from Sep 6, 2024 | |
| 71335-2165-4 | 71335216504 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4)Marketed from Sep 6, 2024 | |
| 71335-2165-5 | 71335216505 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5)Marketed from Sep 6, 2024 | |
| 71335-2165-6 | 71335216506 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6)Marketed from Sep 6, 2024 | |
| 71335-2165-7 | 71335216507 | 12 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7)Marketed from Nov 8, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- fexofenadine hcl
- Generic name (nonproprietary)
- fexofenadine hcl
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-2165_04a27808-de0a-4100-9aff-3168e4fd231eSPL ID 04a27808-de0a-4100-9aff-3168e4fd231eSPL set ID c23ad304-a5de-454e-a135-4eb143af2381RxCUI 997501UNII 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
N471335216501followed by a unit qualifier and the quantityPackage 71335-2165-01. 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 sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | SPIRIT PHARMACEUTICALS LLC | 68210-2210 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | SPIRIT PHARMACEUTICALS LLC | 68210-4090 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Advanced Rx LLC | 80513-506 |
| Gencare-Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-068 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-202 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-201 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Capsule, CoatedOral | Allegiant Health | 69168-416 |
| Curist Allergy Relieffexofenadine hydrochloride 180 mg | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Little Pharma, Inc. | 72559-027 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Bi-Mart | 37835-601 |
| Curist Hives Relieffexofenadine hydrochloride 180 mg | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Little Pharma, Inc. | 72559-028 |
| Fexofenadine Hydrochloridefexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-231 |
| 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 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-905 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA CORP | 73581-011 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Magno-Humphries, Inc. | 54257-170 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA CORP | 73581-103 |
| 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 |
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