Over-the-counter drug · ANDA
fexofenadine hcl NDC 71610-905
Fexofenadine hydrochloride 180 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71610-905Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0905Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-905-30 | 7161009053071610090530 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-905-30)Marketed from May 7, 2025 | |
| 71610-905-53 | 7161009055371610090553 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53)Marketed from May 7, 2025 | |
| 71610-905-60 | 7161009056071610090560 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60)Marketed from May 7, 2025 | |
| 71610-905-80 | 7161009058071610090580 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80)Marketed from May 7, 2025 |
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)
- fexofenadine hcl
- Generic name (nonproprietary)
- fexofenadine hcl
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-905_34917b34-89a7-2a13-e063-6394a90a9038SPL ID 34917b34-89a7-2a13-e063-6394a90a9038SPL set ID 34918a5a-c4c9-bc79-e063-6294a90acb85RxCUI 997420UNII 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
N471610090530followed by a unit qualifier and the quantityPackage 71610-0905-30. 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.
About NDC 71610-905
- What is NDC 71610-905?
- 71610-905 is the product NDC for fexofenadine hcl, Fexofenadine hydrochloride 180 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- fexofenadine hcl.
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for fexofenadine hcl?
- 45 other product NDCs are listed under this name. See all fexofenadine hcl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other fexofenadine hcl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fexofenadine HCL | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA Corp | 73581-010 | 73581-0010-0173581-0010-0673581-0010-10+1 more |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walmart Inc. | 79903-358 | 79903-0358-3079903-0358-4579903-0358-90 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Strategic Sourcing Services | 70677-1256 | 70677-1256-0170677-1256-02 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals | 77771-202 | 77771-0202-0177771-0202-0577771-0202-30 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals | 77771-201 | 77771-0201-0177771-0201-05 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Rite Aid | 11822-7661 | 11822-7661-05 |
| Fexofenadine HCl | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Rite Aid | 11822-7652 | 11822-7652-04 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Rite Aid | 11822-7663 | 11822-7663-04 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Rite Aid | 11822-7660 | 11822-7660-0311822-7660-0711822-7660-09 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Rite Aid | 11822-7664 | 11822-7664-05 |
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 |
|---|---|---|---|---|
| IAllergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | Safeway, Inc. | 21130-405 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2165 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-701 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-893 |
| Curist Allergy Relieffexofenadine hydrochloride 180 mg | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Little Pharma, Inc. | 72559-027 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Magno-Humphries, Inc. | 54257-170 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Akron Pharma Inc. | 71399-8042 |
| Curist Hives Relieffexofenadine hydrochloride 180 mg | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Little Pharma, Inc. | 72559-028 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-801 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | NUVICARE LLC | 84324-045 |
| 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 | Proficient Rx LP | 63187-921 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA CORP | 73581-011 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Bi-Mart | 37835-601 |
| Fexofenadine HCl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Camber Consumer Care | 69230-202 |
| Fexofenadine HCl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Camber Consumer Care | 69230-201 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA CORP | 73581-103 |
| fexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7192 |
| fexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals | 77771-202 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | SPIRIT PHARMACEUTICALS LLC | 68210-2210 |
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