SIMPEX Guaifenesin
- Product NDC
- 76457-004
- 11-digit product format
- 764570004
- Labeler code
- 76457
- Product ID
- 76457-004_0b586737-4616-db6e-e063-6294a90a6135
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Simpex Pharma Pvt. Ltd
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-02-09
- Substance
- GUAIFENESIN
- Active strength
- 400 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
- SIMPEX Guaifenesin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 359601 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76457-004-00 | SIMPEX Guaifenesin | 100 in 1 CARTON | TABLET | 100 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76457-004 | SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231201_1594f9d6-0c48-42bf-b76b-d621f215179a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76457-004-00 | 76457000400 | 100 TABLET in 1 CARTON (76457-004-00) | 100 tablet | 2018-02-09 | 0000-00-00 | No | No | Current |