sumatriptan succinate
- Product NDC
- 62756-521
- 11-digit product format
- 627560521
- Labeler code
- 62756
- Product ID
- 62756-521_9035f04f-b353-4883-9ac2-e030f18bfc1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sumatriptan succinate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078295
- Marketing category
- ANDA
- Marketing start
- 2009-08-10
- 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 succinate
- 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 |
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SUMATRIPTAN SUCCINATE | ACTIVE INGREDIENT | J8BDZ68989 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| SUMATRIPTAN | ACTIVE MOIETY | 8R78F6L9VO | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | |
| SUMATRIPTAN SUCCINATE | ACTIVE INGREDIENT | J8BDZ68989 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| SUMATRIPTAN | ACTIVE MOIETY | 8R78F6L9VO | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-521 | SUMATRIPTAN SUCCINATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 14 | Current NDC, Legacy NDC | 20240301_9485cc30-15e8-4b53-876d-db317145474b.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 |
|---|
| 62756-521-01 | 62756052101 | 3 BLISTER PACK in 1 CARTON (62756-521-01) / 9 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2020-11-01 | 0000-00-00 | No | No | Current |
| 62756-521-08 | 62756052108 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-521-08) | | 2009-08-10 | 0000-00-00 | No | No | Current |
| 62756-521-18 | 62756052118 | 1000 TABLET, FILM COATED in 1 BOTTLE (62756-521-18) | | 2009-08-10 | 0000-00-00 | No | No | Current |
| 62756-521-69 | 62756052169 | 9 BLISTER PACK in 1 CARTON (62756-521-69) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2009-08-10 | 0000-00-00 | No | No | Current |
| 62756-521-83 | 62756052183 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-521-83) | | 2009-08-10 | 0000-00-00 | No | No | Current |
| 62756-521-88 | 62756052188 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-521-88) | | 2009-08-10 | 0000-00-00 | No | No | Current |
| 62756-521-93 | 62756052193 | 9 BLISTER PACK in 1 CARTON (62756-521-93) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2009-08-10 | 0000-00-00 | No | No | Current |