Guaifenesin
- Product NDC
- 21130-179
- 11-digit product format
- 211300179
- Labeler code
- 21130
- Product ID
- 21130-179_449da1ee-474d-477e-843b-39b442501809
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Better Living Brands LLC
- Application
- ANDA210453
- Marketing category
- ANDA
- Marketing start
- 2022-04-15
- Substance
- GUAIFENESIN
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 636522 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21130-179-67 | Guaifenesin | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 3 |
| 21130-179-67 | Guaifenesin | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21130-179 | GUAIFENESIN TABLET, EXTENDED RELEASE [BETTER LIVING BRANDS LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231202_ba6ccfc6-d2f8-56d0-e053-2a95a90af6a8.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 |
|---|
| 21130-179-67 | 21130017967 | 1 BLISTER PACK in 1 CARTON (21130-179-67) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2022-04-15 | 0000-00-00 | No | No | Current |