Over-the-counter drug · ANDA
Fexofenadine Hydrochloride (fexofenadine hydrochloride oral) NDC 58602-426
Fexofenadine hydrochloride 30 mg/5mL · Suspension · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-426-20 | 58602042620 | 1 BOTTLE in 1 CARTON (58602-426-20) / 240 mL in 1 BOTTLEMarketed from May 23, 2023 | |
| 58602-426-24 | 58602042624 | 1 BOTTLE in 1 CARTON (58602-426-24) / 120 mL in 1 BOTTLEMarketed from May 23, 2023 |
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
- Generic name (nonproprietary)
- fexofenadine hydrochloride oral
- Active ingredients
- Fexofenadine hydrochloride — 30 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213466
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-426_a75ff860-f7e0-4e19-846b-fbe33e0e1dfdSPL ID a75ff860-f7e0-4e19-846b-fbe33e0e1dfdSPL set ID e8e35d7a-a86b-4d37-979b-f454978f070bRxCUI 997491UNII 2S068B75ZUUPC 0358602426200
- 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
N458602042620followed by a unit qualifier and the quantityPackage 58602-0426-20. 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)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213466
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 Hydrochloridefexofenadine hydrochloride oral | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-427 |