Over-the-counter drug · ANDA
Fexofenadine HCl and Pseudoephedrine HCI NDC 59779-508
Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59779-508-14 | 59779050814 | 4 BLISTER PACK in 1 CARTON (59779-508-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 19, 2014 | |
| 59779-508-31 | 59779050831 | 6 BLISTER PACK in 1 CARTON (59779-508-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 19, 2014 |
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 and Pseudoephedrine HCI
- Generic name (nonproprietary)
- fexofenadine hcl and pseudoephedrine hci
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- CVS Pharmacy
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076667
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 59779-508_aac03106-806f-bc8c-056c-bed65497dd54SPL ID aac03106-806f-bc8c-056c-bed65497dd54SPL set ID 3e295047-1a46-a0d8-2e3f-ec4086f5aedbRxCUI 997406UNII 2S068B75ZU, 6V9V2RYJ8N
- Pharmacologic class
- Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist
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
N459779050814followed by a unit qualifier and the quantityPackage 59779-0508-14. 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 nasal congestion itchy, watery eyes itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076667
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 HCl and Pseudoephedrine HCI | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Walgreens Company | 0363-1606 |
| Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | HEB | 37808-022 |
| Allergy and Congestionfexofenadine hcl and pseudoephedrine hci | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-7388 |
| Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Limited | 55111-447 |
| Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | The Kroger Co. | 30142-447 |
| Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | The Kroger Co. | 30142-611 |
| Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-823 |