Guaifenesin and Pseudoephedrine HCl
- Product NDC
- 46122-801
- 11-digit product format
- 461220801
- Labeler code
- 46122
- Product ID
- 46122-801_775000bc-56de-4c72-87da-65bb33f063b3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine HCl
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amerisource Bergen
- Application
- ANDA213203
- Marketing category
- ANDA
- Marketing start
- 2024-10-01
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 600; 60 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 |
|---|
| 495W7451VQ | GUAIFENESIN | 93-14-1 | GUAIFENESIN |
| 6V9V2RYJ8N | PSEUDOEPHEDRINE HYDROCHLORIDE | 345-78-8 | PSEUDOEPHEDRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46122-801-08 | 46122080108 | 1 BLISTER PACK in 1 CARTON (46122-801-08) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2024-10-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | Amerisource Bergen | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2024-12-03 | Human OTC Drug Label | 1 |