Over-the-counter drug · ANDA
Fexofenadine HCl and Pseudoephedrine HCI NDC 55111-557
Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1 · Tablet, Extended release · Oral · Dr.Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-557-07 | 55111055707 | 1 BLISTER PACK in 1 CARTON (55111-557-07) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 24, 2011 | |
| 55111-557-29 | 55111055729 | 3 BLISTER PACK in 1 CARTON (55111-557-29) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 24, 2011 | |
| 55111-557-35 | 55111055735 | 2 BLISTER PACK in 1 CARTON (55111-557-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 24, 2011 |
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 — 180 mg/1Pseudoephedrine hydrochloride — 240 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079043
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55111-557_29216032-68a5-566a-5eaf-ffc9cb597e9aSPL ID 29216032-68a5-566a-5eaf-ffc9cb597e9aSPL set ID 25cca459-fdd6-3847-2207-dd4f019781b5RxCUI 997415UNII 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
N455111055707followed by a unit qualifier and the quantityPackage 55111-0557-07. 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 relieves 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.