Guaifenesin
- Product NDC
- 68196-405
- 11-digit product format
- 681960405
- Labeler code
- 68196
- Product ID
- 68196-405_4653b224-fef8-1541-e063-6394a90a94bd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SAM'S WEST INC
- Application
- ANDA213420
- Marketing category
- ANDA
- Marketing start
- 2023-10-06
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68196-405-14 | Guaifenesin | 56 in 1 BLISTER PACK | TABLET | 56 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68196-405 | GUAIFENESIN TABLET [SAM'S WEST INC] | 5 | Current NDC, 1 package rows | 20241120_00c40e3b-6962-dfb4-e063-6294a90afec6.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 |
|---|
| 68196-405-14 | 68196040514 | 56 TABLET in 1 BLISTER PACK (68196-405-14) | 56 tablet | 2023-10-06 | No | No | Historical |