Over-the-counter drug · ANDA
Allergy Relief (fexofenadine hydrochloride) NDC 36800-653
Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · TOPCO ASSOCIATES LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-653-03 | 36800065303 | 1 BLISTER PACK in 1 CARTON (36800-653-03) / 15 TABLET in 1 BLISTER PACKMarketed from Sep 10, 2021 | |
| 36800-653-07 | 36800065307 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-653-07) / 60 TABLET in 1 BOTTLE, PLASTICMarketed from Dec 8, 2022 | |
| 36800-653-11 | 36800065311 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-653-11) / 150 TABLET in 1 BOTTLE, PLASTICMarketed from Dec 8, 2023 |
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)
- Allergy Relief
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TOPCO ASSOCIATES LLC
- 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 36800-653_08f3ce32-81a9-f9d2-e063-6394a90ab17dSPL ID 08f3ce32-81a9-f9d2-e063-6394a90ab17dSPL set ID c4f9224c-4c3d-74bd-e053-2995a90a1452RxCUI 997420UNII 2S068B75ZUUPC 0036800492301
- 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
N436800065303followed by a unit qualifier and the quantityPackage 36800-0653-03. 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)
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.
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 |
|---|---|---|---|---|
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-801 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Safeway, Inc. | 21130-451 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | AAA PHARMACEUTICAL, INC. | 57344-292 |
| Cabinet Allergy Relief Fexofenadinefexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-3002 |
| Cabinet Allergy Relief Fexofenadinefexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-3002 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | RETAIL BUSINESS SERVICES , LLC. | 72476-192 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS | 51316-767 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CVS | 51316-768 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | TARGET CORPORATION | 11673-767 |
| Crcle Fexofenadine Hydrochloridefexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-240 |
| Crcle Fexofenadine Hydrochloridefexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-230 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walgreens | 0363-9760 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Granules India Limited | 62207-623 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | HEB | 37808-392 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Granules India Ltd | 62207-765 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Granules India Ltd | 62207-766 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Chain Drug Marketing Association, Inc. | 83324-009 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | GRANULES PHARMACEUTICALS INC. | 70010-183 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walgreens | 0363-6231 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Granules India Limited | 62207-889 |
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