Guaifenesin
- Product NDC
- 71179-002
- 11-digit product format
- 711790002
- Labeler code
- 71179
- Product ID
- 71179-002_92017a98-db41-475b-bccf-cab449b6d56c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- VESPYR BRANDS LLC
- Application
- ANDA210453
- Marketing category
- ANDA
- Marketing start
- 2022-06-27
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin
- Listing expiration
- 2027-12-31
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 |
|---|
| 71179-002-21 | Guaifenesin | 7 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 7 | | 3 |
| 71179-002-21 | Guaifenesin | 3 in 1 CARTON | TABLET, EXTENDED RELEASE | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71179-002 | GUAIFENESIN TABLET, EXTENDED RELEASE [VESPYR BRANDS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20231202_e2e3c628-d241-42b6-8c1e-ef997ffa6e87.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 |
|---|
| 71179-002-21 | 71179000221 | 3 BLISTER PACK in 1 CARTON (71179-002-21) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2022-06-27 | 0000-00-00 | No | No | Current |