Over-the-counter drug · ANDA
Fexofenadine Hydrochloride NDC 51316-800
Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · CVS PHARMACY, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-800-08 | 5131608000851316080008 | 1 BOTTLE in 1 CARTON (51316-800-08) / 180 TABLET in 1 BOTTLEMarketed from Sep 20, 2022 | |
| 51316-800-15 | 5131608001551316080015 | 1 BLISTER PACK in 1 CARTON (51316-800-15) / 15 TABLET in 1 BLISTER PACKMarketed from Sep 20, 2022 | |
| 51316-800-30 | 5131608003051316080030 | 1 BOTTLE in 1 CARTON (51316-800-30) / 30 TABLET in 1 BOTTLEMarketed from Sep 20, 2022 | |
| 51316-800-45 | 5131608004551316080045 | 1 BOTTLE in 1 CARTON (51316-800-45) / 45 TABLET in 1 BOTTLEMarketed from Sep 20, 2022 | |
| 51316-800-70 | 5131608007051316080070 | 1 BOTTLE in 1 CARTON (51316-800-70) / 70 TABLET in 1 BOTTLEMarketed from Sep 20, 2022 | |
| 51316-800-90 | 5131608009051316080090 | 1 BOTTLE in 1 CARTON (51316-800-90) / 90 TABLET in 1 BOTTLEMarketed from Sep 20, 2022 |
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 Hydrochloride
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- CVS PHARMACY, INCNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091567
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-800_e6bae65e-9f41-4976-bebd-c14e86da14cbSPL ID e6bae65e-9f41-4976-bebd-c14e86da14cbSPL set ID 7bc13851-291a-4582-8261-13c5022fbdd1RxCUI 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
N451316080008followed by a unit qualifier and the quantityPackage 51316-0800-08. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 51316-800
- What is NDC 51316-800?
- 51316-800 is the product NDC for Fexofenadine Hydrochloride, Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by CVS PHARMACY, INC. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fexofenadine Hydrochloride.
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- CVS PHARMACY, INC, 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 Fexofenadine Hydrochloride?
- 42 other product NDCs are listed under this name. See all Fexofenadine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fexofenadine Hydrochloride 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 Hydrochloridefexofenadine hydrochloride oral | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-427 | 58602-0427-2058602-0427-24 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | NUVICARE LLC | 84324-045 | 84324-0045-01 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA Corp | 73581-025 | 73581-0025-0173581-0025-0673581-0025-20 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA Corp | 73581-026 | 73581-0026-0173581-0026-1073581-0026-20 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA Corp | 73581-027 | 73581-0027-0173581-0027-0473581-0027-10+1 more |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | AMZ789 LLC | 73629-008 | 73629-0008-03 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-008 | 84324-0008-01 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | AMERISOURCE BERGEN | 46122-779 | 46122-0779-5846122-0779-6146122-0779-66 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-010 | 72090-0010-01 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Granules India Limited | 62207-889 | 62207-0889-4962207-0889-5162207-0889-60 |
Other NDCs under ANDA 091567
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8648 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | AMERISOURCE BERGEN | 46122-779 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | OHM LABORATORIES INC. | 51660-998 |