Sumatriptan
- Product NDC
- 80425-0475
- 11-digit product format
- 804250475
- Labeler code
- 80425
- Product ID
- 80425-0475_2aab828f-48fd-5ff9-e063-6394a90ac966
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sumatriptan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA078284
- Marketing category
- ANDA
- Marketing start
- 2024-12-30
- Substance
- SUMATRIPTAN SUCCINATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sumatriptan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SUMATRIPTAN SUCCINATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J8BDZ68989 |
| Rxcui | 313161 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0475-1 | Sumatriptan | 9 in 1 BLISTER PACK | TABLET, FILM COATED | 9 | | 1 |
| 80425-0475-1 | Sumatriptan | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0475 | SUMATRIPTAN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 2 package rows | 20250103_2aab8786-b225-833a-e063-6394a90ac7ae.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 |
|---|
| 80425-0475-1 | 80425047501 | 1 BLISTER PACK in 1 CARTON (80425-0475-1) / 9 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2024-12-30 | No | No | Current |