Phenytoin Sodium
- Product NDC
- 29300-379
- 11-digit product format
- 293000379
- Labeler code
- 29300
- Product ID
- 29300-379_a6527387-ec89-41a1-b85a-c0fb7b4a7db7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA213834
- Marketing category
- ANDA
- Marketing start
- 2022-11-12
- Substance
- PHENYTOIN SODIUM
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4182431BJH |
| Rxcui | 855671 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-379-01 | Phenytoin Sodium | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 6 |
| 29300-379-05 | Phenytoin Sodium | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 6 |
| 29300-379-10 | Phenytoin Sodium | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-379 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20221112_afdf66e0-5f99-444e-bc06-2fdddc507f5c.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 |
|---|
| 29300-379-01 | 29300037901 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-01) | 2022-11-12 | 0000-00-00 | No | No | Current |
| 29300-379-05 | 29300037905 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-05) | 2022-11-12 | 0000-00-00 | No | No | Current |
| 29300-379-10 | 29300037910 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-10) | 2022-11-12 | 0000-00-00 | No | No | Current |