Over-the-counter drug · ANDA
Fexofenadine Hydrochloride NDC 73629-008
Fexofenadine hydrochloride 180 mg/1 · Tablet, Film coated · Oral · AMZ789 LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73629-008-03 | 7362900080373629000803 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73629-008-03)Marketed from Jul 27, 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, Film coated
- Route
- Oral
- Labeler
- AMZ789 LLCNDC labeler code 73629
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211075
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 73629-008_47d41023-701b-09eb-e063-6294a90a7298SPL ID 47d41023-701b-09eb-e063-6294a90a7298SPL set ID 1e46343f-d6b6-73ba-e063-6394a90acd94RxCUI 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
N473629000803followed by a unit qualifier and the quantityPackage 73629-0008-03. 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)
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, water eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 73629-008
- What is NDC 73629-008?
- 73629-008 is the product NDC for Fexofenadine Hydrochloride, Fexofenadine hydrochloride 180 mg/1 tablet, film coated, listed with the FDA by AMZ789 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?
- AMZ789 LLC, NDC labeler code 73629. 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 | 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 |
| 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 211075
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 |
|---|---|---|---|---|
| 12HR Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | CARDINAL HEALTH | 70000-0586 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Safeway, Inc. | 21130-451 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Safeway, Inc. | 21130-821 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | TOPCO ASSOCIATES LLC | 36800-653 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | HEB | 37808-391 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | HEB | 37808-392 |
| allergy relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-292 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | HYVEE INC | 42507-192 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-801 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | DISCOUNT DRUG MART | 53943-392 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Family Dollar (FAMILY WELLNESS) | 55319-965 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | AAA PHARMACEUTICAL, INC. | 57344-292 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | AMERIFOODS TRADING COMPANY | 61504-192 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-334 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-801 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | MARC GLASSMAN, INC. | 68998-292 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Capsule, CoatedOral | Allegiant Health | 69168-413 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | CVS PHARMACY | 69842-492 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | HARRIS TEETER | 72036-191 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | HARRIS TEETER | 72036-292 |
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