Sumatriptan
- Product NDC
- 65145-118
- 11-digit product format
- 651450118
- Labeler code
- 65145
- Product ID
- 65145-118_eeefceae-7dbe-4215-90b2-59b5d509547f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sumatriptan
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA213998
- Marketing category
- ANDA
- Marketing start
- 2024-09-28
- Substance
- SUMATRIPTAN SUCCINATE
- Active strength
- 6 mg/.5mL
- 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 | 6 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J8BDZ68989 |
| Rxcui | 313165 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-118-01 | Sumatriptan | 0.5 mL in 1 VIAL | INJECTION, SOLUTION | 0.5 | | 6 |
| 65145-118-05 | Sumatriptan | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-118 | SUMATRIPTAN INJECTION, SOLUTION [CAPLIN STERILES LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240929_01293e09-d49a-411d-9647-6f23318ac201.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 |
|---|
| 65145-118-01 | 65145011801 | 0.5 mL in 1 VIAL | 0.5 ml | | | | | Historical |
| 65145-118-05 | 65145011805 | 5 VIAL in 1 CARTON (65145-118-05) / .5 mL in 1 VIAL (65145-118-01) | 5 vial | 2024-09-28 | 0000-00-00 | No | No | Current |