Guaifenesin
- Product NDC
- 46122-750
- 11-digit product format
- 461220750
- Labeler code
- 46122
- Product ID
- 46122-750_335ad6a0-0537-b0e1-e063-6294a90a83b5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AMERISOURCE BERGEN
- Application
- ANDA209254
- Marketing category
- ANDA
- Marketing start
- 2023-08-11
- 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 |
|---|
| 46122-750-51 | Guaifenesin | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 3 |
| 46122-750-51 | Guaifenesin | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46122-750 | GUAIFENESIN TABLET, EXTENDED RELEASE [AMERISOURCE BERGEN] | 3 | Current NDC, 2 package rows | 20250424_d1d94d37-4423-4914-9d86-c5ca6d5122f6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46122-750-51 | 46122075051 | 2 BLISTER PACK in 1 CARTON (46122-750-51) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2023-08-11 | No | No | Historical |