Guaifenesin
- Product NDC
- 76162-031
- 11-digit product format
- 761620031
- Labeler code
- 76162
- Product ID
- 76162-031_df5d7fac-fdbc-4ebd-bcb9-0e67a891101f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- TOPCO ASSOCIATES LLC
- Application
- ANDA210453
- Marketing category
- ANDA
- Marketing start
- 2026-04-22
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 1200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 310621 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76162-031-56 | Guaifenesin | 4 in 1 CARTON | TABLET, EXTENDED RELEASE | 4 | | 2 |
| 76162-031-56 | Guaifenesin | 14 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 14 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-031-56 | 76162003156 | 4 BLISTER PACK in 1 CARTON (76162-031-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2026-04-22 | No | No | Current |