Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 0536-1431
- 11-digit product format
- 005361431
- Labeler code
- 0536
- Product ID
- 0536-1431_cc6df813-9175-4c0b-a8e4-afcaa3aa833f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- ANDA209116
- Marketing category
- ANDA
- Marketing start
- 2024-05-17
- 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 |
|---|
| 0536-1431-07 | 00536143107 | 3 BLISTER PACK in 1 CARTON (0536-1431-07) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2024-05-17 | No | No | Historical |
| 0536-1431-34 | 00536143134 | 2 BLISTER PACK in 1 CARTON (0536-1431-34) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2024-05-17 | No | No | Historical |