Topcare Mucus ER
- Product NDC
- 76162-409
- 11-digit product format
- 761620409
- Labeler code
- 76162
- Product ID
- 76162-409_d46da7e9-49e2-4d0b-8a68-6eed1e0bf145
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- guaifenesin
- Dosage form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA078912
- Marketing category
- ANDA
- Marketing start
- 2025-03-26
- Substance
- GUAIFENESIN
- Active strength
- 1200 mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- 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 |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-409-01 | 76162040901 | 4 BLISTER PACK in 1 CARTON (76162-409-01) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2025-04-09 | No | No | Historical |
| 76162-409-74 | 76162040974 | 2 BLISTER PACK in 1 CARTON (76162-409-74) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2025-03-26 | No | No | Historical |