Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 58602-844
- 11-digit product format
- 586020844
- Labeler code
- 58602
- Product ID
- 58602-844_bced0a2e-047e-456e-bbd2-495e83bf07ee
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA215232
- Marketing category
- ANDA
- Marketing start
- 2025-04-17
- Substance
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 180; 240 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2S068B75ZU | FEXOFENADINE HYDROCHLORIDE | 153439-40-8 | FEXOFENADINE HYDROCHLORIDE |
| 6V9V2RYJ8N | PSEUDOEPHEDRINE HYDROCHLORIDE | 345-78-8 | PSEUDOEPHEDRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58602-844-60 | 58602084460 | 1 BLISTER PACK in 1 CARTON (58602-844-60) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2025-04-17 | No | No | Historical |
| 58602-844-66 | 58602084466 | 2 BLISTER PACK in 1 CARTON (58602-844-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2025-04-17 | No | No | Historical |
| 58602-844-85 | 58602084485 | 3 BLISTER PACK in 1 CARTON (58602-844-85) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2025-04-17 | No | No | Historical |