Guaifenesin and Pseudoephedrine HCl
- Product NDC
- 70677-1263
- 11-digit product format
- 706771263
- Labeler code
- 70677
- Product ID
- 70677-1263_27f84be6-4c43-19eb-e063-6394a90a368c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine HCl
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Strategic Sourcing Services LLC
- Application
- ANDA212542
- Marketing category
- ANDA
- Marketing start
- 2024-12-13
- 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 |
|---|
| 70677-1263-1 | 70677126301 | 1 BLISTER PACK in 1 CARTON (70677-1263-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2024-12-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | Strategic Sourcing Services LLC | Ohm Laboratories, Inc. | 2024-11-28 | HUMAN OTC DRUG LABEL | 1 |