phenytoin sodium
- Product NDC
- 62756-432
- 11-digit product format
- 627560432
- Labeler code
- 62756
- Product ID
- 62756-432_c89dfc75-606c-4a4e-9d2b-d907b492a837
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phenytoin sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA040731
- Marketing category
- ANDA
- Marketing start
- 2008-06-30
- Substance
- PHENYTOIN SODIUM
- Active strength
- 300 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- phenytoin sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYTOIN SODIUM | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4182431BJH |
| Rxcui | 855861, 855873 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62756-432-08 | phenytoin sodium | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 7 |
| 62756-432-13 | phenytoin sodium | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 7 |
| 62756-432-83 | phenytoin sodium | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 7 |
| 62756-432-88 | phenytoin sodium | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENYTOIN SODIUM | ACTIVE INGREDIENT | 4182431BJH | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| PHENYTOIN | ACTIVE MOIETY | 6158TKW0C5 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| LACTITOL MONOHYDRATE | INACTIVE INGREDIENT | UH2K6W1Y64 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-432 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20221228_c40f66cc-6f4a-4b29-84ba-d265e4848735.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62756-432-08 | 62756043208 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-432-08) | 2008-06-30 | 0000-00-00 | No | No | Current |
| 62756-432-13 | 62756043213 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-432-13) | 2008-06-30 | 0000-00-00 | No | No | Current |
| 62756-432-83 | 62756043283 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-432-83) | 2008-06-30 | 0000-00-00 | No | No | Current |
| 62756-432-88 | 62756043288 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-432-88) | 2008-06-30 | 0000-00-00 | No | No | Current |