Pseudoephedrine hydrochloride
- Product NDC
- 0904-7409
- 11-digit product format
- 009047409
- Labeler code
- 0904
- Product ID
- 0904-7409_1b23c014-95b2-ac65-e063-6294a90a5d5d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA077442
- Marketing category
- ANDA
- Marketing start
- 2024-06-07
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], 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 |
|---|
| 6V9V2RYJ8N | PSEUDOEPHEDRINE HYDROCHLORIDE | 345-78-8 | PSEUDOEPHEDRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7409-15 | 00904740915 | 1 BLISTER PACK in 1 CARTON (0904-7409-15) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2024-06-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pseudoephedrine hydrochloride | Major Pharmaceuticals | Ohm Laboratories Inc. | 2024-06-18 | HUMAN OTC DRUG LABEL | 2 |