Over-the-counter drug · ANDA
CVS Fexofenadine Hydrochloride (Fexofenadine hydrochloride) NDC 51316-183
Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-183-00 | 5131601830051316018300 | 180 TABLET in 1 BOTTLE (51316-183-00)Marketed from Oct 22, 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)
- CVS Fexofenadine Hydrochloride
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- CVS PharmacyNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210137
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-183_41c5bbff-5362-e7e2-e063-6294a90a5fc2SPL ID 41c5bbff-5362-e7e2-e063-6294a90a5fc2SPL set ID 3d6c7b10-ed05-bbde-e063-6294a90ae92fRxCUI 997420UNII 2S068B75ZUUPC 0050428000618
- 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
N451316018300followed by a unit qualifier and the quantityPackage 51316-0183-00. 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 51316-183
- What is NDC 51316-183?
- 51316-183 is the product NDC for CVS Fexofenadine Hydrochloride (fexofenadine hydrochloride), Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by CVS Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CVS Fexofenadine Hydrochloride (Fexofenadine hydrochloride).
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- CVS Pharmacy, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CVS Fexofenadine Hydrochloride?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 210137
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 HCl | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services, LLC | 70677-1239 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-010 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA Corp | 73581-027 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-008 |
| Gencare Hives Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-058 |
| Nuvicare Hives Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-031 |