Over-the-counter drug · ANDA
Fexofenadine HCL NDC 72789-196
Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-196-10 | 72789019610 | 10 TABLET in 1 BOTTLE, PLASTIC (72789-196-10)Marketed from Mar 14, 2023 | |
| 72789-196-30 | 72789019630 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-196-30)Marketed from Sep 15, 2022 | |
| 72789-196-90 | 72789019690 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-196-90)Marketed from Jul 6, 2021 |
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 HCL
- Generic name (nonproprietary)
- fexofenadine hcl
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204097
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72789-196_40ac042c-0bf7-c7f4-e063-6294a90a4094SPL ID 40ac042c-0bf7-c7f4-e063-6294a90a4094SPL set ID 07460764-43fa-49fd-ae77-d4571cb9f944RxCUI 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
N472789019610followed by a unit qualifier and the quantityPackage 72789-0196-10. 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)
USE(S) 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 204097
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 |
|---|---|---|---|---|
| ValuMeds Non-Drowsy Allergy Relief Fexofenadine HClfexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1202 |
| Goodmeds Non Drowsy Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-4202 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7449 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NorthStar RxLLC | 16714-899 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walmart Inc. | 79903-358 |
| Allergy Relief | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Allegiant Health | 69168-450 |
| Fexofenadine HCL | Fexofenadine hydrochloride 60 mg/1 | TabletOral | YYBA Corp | 73581-010 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | YYBA Corp | 73581-009 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1217 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Camber Consumer Care | 69230-300 |
| 24HR Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0726 |
| Fexofenadine HCL | Fexofenadine hydrochloride 60 mg/1 | TabletOral | Camber Consumer Care | 69230-301 |
| equate allergy relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walmart Inc. | 49035-366 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Proficient Rx LP | 71205-531 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | A-S Medication Solutions | 50090-4070 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-854 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | A-S Medication Solutions | 50090-6965 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, CoatedOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0663 |
| Childrens Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 30 mg/1 | TabletOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0662 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0664 |
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