GUAIFENESIN
- Product NDC
- 71309-461
- 11-digit product format
- 713090461
- Labeler code
- 71309
- Product ID
- 71309-461_f7f18eb7-a4bc-b7f6-e053-6394a90a0f74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Safrel Pharmaceuticals, LLC.
- Application
- ANDA213420
- Marketing category
- ANDA
- Marketing start
- 2020-12-18
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71309-461-56 | GUAIFENESIN | 56 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 56 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71309-461 | GUAIFENESIN TABLET, EXTENDED RELEASE [SAFREL PHARMACEUTICALS, LLC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230329_e2a3d6cb-5251-b88e-e053-2a95a90a9e30.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71309-461-56 | 71309046156 | 56 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-461-56) | 2022-06-29 | 0000-00-00 | No | No | Current |