Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 70677-1010
- 11-digit product format
- 706771010
- Labeler code
- 70677
- Product ID
- 70677-1010_c604326c-44ff-2c88-4d4f-d5279566bf8d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Strategic Sourcing Services, LLC
- Application
- ANDA215434
- Marketing category
- ANDA
- Marketing start
- 2022-03-31
- 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 |
|---|
| 70677-1010-1 | 70677101001 | 4 BLISTER PACK in 1 CARTON (70677-1010-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2023-05-05 | No | No | Historical |