Guaifenesin 1200 mg
- Product NDC
- 25000-041
- 11-digit product format
- 250000041
- Labeler code
- 25000
- Product ID
- 25000-041_0af3bdb4-c1f3-4941-a1de-6e08c49849cb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin 1200 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA217780
- Marketing category
- ANDA
- Marketing start
- 2023-08-23
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin 1200 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 1200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 310621, 636522 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-041-12 | Guaifenesin 1200 mg | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 25000-041-34 | Guaifenesin 1200 mg | 2 in 1 CARTON | TABLET | 2 | | 6 |
| 25000-041-34 | Guaifenesin 1200 mg | 14 in 1 BLISTER PACK | TABLET | 14 | | 6 |
| 25000-041-75 | Guaifenesin 1200 mg | 2 in 1 CARTON | TABLET | 2 | | 6 |
| 25000-041-75 | Guaifenesin 1200 mg | 6 in 1 BLISTER PACK | TABLET | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-041 | GUAIFENESIN 600 MG TABLET GUAIFENESIN 1200 MG TABLET [MARKSANS PHARMA LIMITED] | 4 | Current NDC, 5 package rows | 20250426_fedf43d0-d6d1-4f50-bbab-396701e45cb2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25000-041-12 | 25000004112 | 500 TABLET in 1 BOTTLE (25000-041-12) | 500 tablet | 2023-08-23 | No | No | Current |
| 25000-041-34 | 25000004134 | 2 BLISTER PACK in 1 CARTON (25000-041-34) / 14 TABLET in 1 BLISTER PACK | 2 blister pack | 2025-04-18 | No | No | Current |
| 25000-041-75 | 25000004175 | 2 BLISTER PACK in 1 CARTON (25000-041-75) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2023-08-23 | No | No | Current |