Guaifenesin
- Product NDC
- 65162-036
- 11-digit product format
- 651620036
- Labeler code
- 65162
- Product ID
- 65162-036_f1b3934b-1fc2-4ce8-9465-e1f031daf9c5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA207342
- Marketing category
- ANDA
- Marketing start
- 2018-07-27
- 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-036-02 | Guaifenesin | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 12 |
| 65162-036-02 | Guaifenesin | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 12 |
| 65162-036-03 | Guaifenesin | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 12 |
| 65162-036-03 | Guaifenesin | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 12 |
| 65162-036-06 | Guaifenesin | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 12 |
| 65162-036-06 | Guaifenesin | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-036 | GUAIFENESIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 12 | Current NDC, Legacy NDC, 6 package rows | 20241027_ad67e6fd-a68f-44db-9718-84a2cef86e09.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 |
|---|
| 65162-036-02 | 65162003602 | 2 BLISTER PACK in 1 CARTON (65162-036-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2018-07-27 | 0000-00-00 | No | No | Current |
| 65162-036-03 | 65162003603 | 1 BOTTLE in 1 CARTON (65162-036-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2018-07-27 | 0000-00-00 | No | No | Current |
| 65162-036-06 | 65162003606 | 1 BOTTLE in 1 CARTON (65162-036-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2018-07-27 | 0000-00-00 | No | No | Current |