Guaifenesin
- Product NDC
- 0363-9569
- 11-digit product format
- 003639569
- Labeler code
- 0363
- Product ID
- 0363-9569_46546a5a-8f8f-e73a-e063-6394a90a8330
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Walgreens
- Application
- ANDA213420
- Marketing category
- ANDA
- Marketing start
- 2024-07-19
- 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 |
|---|
| 0363-9569-02 | Guaifenesin | 20 in 1 BLISTER PACK | TABLET | 20 | | 4 |
| 0363-9569-04 | Guaifenesin | 40 in 1 BLISTER PACK | TABLET | 40 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-9569 | GUAIFENESIN TABLET [WALGREENS] | 3 | Current NDC, 2 package rows | 20241222_fd91621b-c969-8851-e053-6294a90ad8b2.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 |
|---|
| 0363-9569-02 | 00363956902 | 20 TABLET in 1 BLISTER PACK (0363-9569-02) | 20 tablet | 2024-07-19 | No | No | Historical |
| 0363-9569-04 | 00363956904 | 40 TABLET in 1 BLISTER PACK (0363-9569-04) | 40 tablet | 2024-07-19 | No | No | Historical |