Over-the-counter drug · ANDA
Allergy and Congestion NDC 11822-7388
fexofenadine hcl and pseudoephedrine hci · Fexofenadine hydrochloride 60 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · Rite Aid Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11822-7388-5 | 11822738805 | 4 BLISTER PACK in 1 CARTON (11822-7388-5) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 19, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 and Congestion
- 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
- Rite Aid Corporation
- 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 11822-7388_0855522f-2405-be3c-f917-1eee93ea396aSPL ID 0855522f-2405-be3c-f917-1eee93ea396aSPL set ID 90e1aa06-b769-e8ac-af88-1d6a256b9487RxCUI 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
N411822738805followed by a unit qualifier and the quantityPackage 11822-7388-05. 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 temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory allergies 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 | CVS Pharmacy | 59779-508 |
| 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 |
| 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 |