Over-the-counter drug · ANDA
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride NDC 58602-844
Fexofenadine hydrochloride 180 mg/1; Pseudoephedrine hydrochloride 240 mg/1 · Tablet, Film coated, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-844-60 | 58602084460 | 1 BLISTER PACK in 1 CARTON (58602-844-60) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 17, 2025 | |
| 58602-844-66 | 58602084466 | 2 BLISTER PACK in 1 CARTON (58602-844-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 17, 2025 | |
| 58602-844-85 | 58602084485 | 3 BLISTER PACK in 1 CARTON (58602-844-85) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 17, 2025 |
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 Hydrochloride and Pseudoephedrine Hydrochloride
- Generic name (nonproprietary)
- fexofenadine hydrochloride and pseudoephedrine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 180 mg/1Pseudoephedrine hydrochloride — 240 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215232
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-844_bced0a2e-047e-456e-bbd2-495e83bf07eeSPL ID bced0a2e-047e-456e-bbd2-495e83bf07eeSPL set ID bced0a2e-047e-456e-bbd2-495e83bf07eeRxCUI 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
N458602084460followed by a unit qualifier and the quantityPackage 58602-0844-60. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.