Guaifenesin Extended Release 600 mg
- Product NDC
- 49483-723
- 11-digit product format
- 494830723
- Labeler code
- 49483
- Product ID
- 49483-723_10c427f2-f75b-9e93-e063-6294a90ab0ef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC.
- Application
- ANDA217780
- Marketing category
- ANDA
- Marketing start
- 2024-01-08
- 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 Extended Release 600 mg
- 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 |
|---|
| 49483-723-50 | Guaifenesin Extended Release 600 mg | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-723 | GUAIFENESIN EXTENDED RELEASE 600 MG (GUAIFENESIN) TABLET GUAIFENESIN EXTENDED RELEASE 1200 MG (GUAIFENESIN) TABLET [TIME CAP LABORATORIES, INC.] | 1 | Current NDC, 1 package rows | 20240208_10c42869-7df0-3046-e063-6394a90aa679.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 |
|---|
| 49483-723-50 | 49483072350 | 500 TABLET in 1 BOTTLE (49483-723-50) | 500 tablet | 2024-01-08 | No | No | Historical |