Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 70000-0677
- 11-digit product format
- 700000677
- Labeler code
- 70000
- Product ID
- 70000-0677_c3b40d04-7eef-4c80-a604-808d2be72ad7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health
- Application
- ANDA209116
- Marketing category
- ANDA
- Marketing start
- 2024-05-15
- Substance
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 60; 120 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 |
|---|
| 70000-0677-1 | 70000067701 | 2 BLISTER PACK in 1 CARTON (70000-0677-1) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2024-05-15 | No | No | Historical |
| 70000-0677-2 | 70000067702 | 3 BLISTER PACK in 1 CARTON (70000-0677-2) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2024-05-15 | No | No | Historical |