Sumatriptan
- Product NDC
- 69452-344
- 11-digit product format
- 694520344
- Labeler code
- 69452
- Product ID
- 69452-344_44354d31-8bcb-491f-8e45-859337c6ca35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sumatriptan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA078284
- Marketing category
- ANDA
- Marketing start
- 2022-02-18
- Substance
- SUMATRIPTAN SUCCINATE
- Active strength
- 25 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sumatriptan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SUMATRIPTAN SUCCINATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J8BDZ68989 |
| Rxcui | 313160, 313161, 315223 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-344-60 | Sumatriptan | 9 in 1 BLISTER PACK | TABLET, FILM COATED | 9 | | 4 |
| 69452-344-72 | Sumatriptan | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-344 | SUMATRIPTAN TABLET, FILM COATED [BIONPHARMA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231209_e90b0eea-c424-4f00-98da-6ed6e80de1f6.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 |
|---|
| 69452-344-60 | 69452034460 | 9 in 1 BLISTER PACK | | | | | | Historical |
| 69452-344-72 | 69452034472 | 1 BLISTER PACK in 1 CARTON (69452-344-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-344-60) | 1 blister pack | 2022-02-18 | 0000-00-00 | No | No | Current |