Over-the-counter drug · ANDA
Fexofenadine Hydrochloride NDC 84324-008
Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · NUVICARE LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84324-008-01 | 8432400080184324000801 | 18 TABLET in 1 BOTTLE (84324-008-01)Marketed from Jul 17, 2024 |
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
- NUVICARE LLCNDC labeler code 84324
- 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 84324-008_16dc8e4f-54e3-4edd-87f8-30d072fabad1SPL ID 16dc8e4f-54e3-4edd-87f8-30d072fabad1SPL set ID bb47b839-3f49-4818-a62c-b6d2b09b15dcRxCUI 997420UNII 2S068B75ZUUPC 0384324000060
- 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
N484324000801followed by a unit qualifier and the quantityPackage 84324-0008-01. 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.
About NDC 84324-008
- What is NDC 84324-008?
- 84324-008 is the product NDC for Fexofenadine Hydrochloride, Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by NUVICARE LLC. It has 1 package NDC, 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?
- NUVICARE LLC, NDC labeler code 84324. 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 | 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 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Granules India Limited | 62207-891 | 62207-0891-4962207-0891-5162207-0891-58 |
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 |
|---|---|---|---|---|
| CVS Fexofenadine Hydrochloridefexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS Pharmacy | 51316-183 |
| 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 |
| 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 |