Guaifenesin
- Product NDC
- 0363-0028
- 11-digit product format
- 003630028
- Labeler code
- 0363
- Product ID
- 0363-0028_4c76abec-f8fe-498d-a322-76b6f45a57f8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- WALGREEN CO.
- Application
- ANDA210453
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- 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
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0363-0028-96 | Guaifenesin | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 7 |
| 0363-0028-96 | Guaifenesin | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | | 7 |
| 0363-0028-97 | Guaifenesin | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | | 7 |
| 0363-0028-97 | Guaifenesin | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 7 |
| 0363-0028-98 | Guaifenesin | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | | 7 |
| 0363-0028-98 | Guaifenesin | 5 in 1 CARTON | TABLET, EXTENDED RELEASE | 5 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-0028 | GUAIFENESIN TABLET, EXTENDED RELEASE [WALGREEN CO.] | 6 | Current NDC, Legacy NDC, 6 package rows | 20241206_51a35002-77ba-47e5-93ab-3f28242d16b6.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 |
|---|
| 0363-0028-96 | 00363002896 | 1 BLISTER PACK in 1 CARTON (0363-0028-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2020-05-08 | 0000-00-00 | No | No | Current |
| 0363-0028-97 | 00363002897 | 2 BLISTER PACK in 1 CARTON (0363-0028-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2020-05-08 | 0000-00-00 | No | No | Current |
| 0363-0028-98 | 00363002898 | 5 BLISTER PACK in 1 CARTON (0363-0028-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 5 blister pack | 2020-05-08 | 0000-00-00 | No | No | Current |