GUAIFENESIN
- Product NDC
- 62207-839
- 11-digit product format
- 622070839
- Labeler code
- 62207
- Product ID
- 62207-839_44f3065d-0001-622b-e063-6394a90a2775
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Granules India Ltd
- Application
- ANDA213420
- Marketing category
- ANDA
- Marketing start
- 2020-12-18
- 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 | 310621, 636522 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62207-839-72 | GUAIFENESIN | 9 in 1 CARTON | TABLET, EXTENDED RELEASE | 9 | | 8 |
| 62207-839-72 | GUAIFENESIN | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-839 | GUAIFENESIN TABLET, EXTENDED RELEASE [GRANULES INDIA LTD] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241004_e3531e9e-2ae7-4188-b95a-90f35613fc05.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 |
|---|
| 62207-839-72 | 62207083972 | 9 BLISTER PACK in 1 CARTON (62207-839-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 9 blister pack | 2020-12-18 | 0000-00-00 | No | No | Current |