Guaifenesin
- Product NDC
- 68001-561
- 11-digit product format
- 680010561
- Labeler code
- 68001
- Product ID
- 68001-561_0c4ee6ca-2596-fbd2-e063-6394a90a0806
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA210453
- Marketing category
- ANDA
- Marketing start
- 2023-03-15
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-561-16 | Guaifenesin | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 4 |
| 68001-561-17 | Guaifenesin | 8 in 1 CARTON | TABLET, EXTENDED RELEASE | 8 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-561 | GUAIFENESIN TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES] | 4 | Current NDC, Legacy NDC, 2 package rows | 20231213_ee8a2a97-16aa-0f3e-e053-2a95a90a523b.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 |
|---|
| 68001-561-16 | 68001056116 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68001-561-17 | 68001056117 | 8 BLISTER PACK in 1 CARTON (68001-561-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68001-561-16) | 8 blister pack | 2023-03-15 | 0000-00-00 | No | No | Current |