Phenytoin
- Product NDC
- 0904-7199
- 11-digit product format
- 009047199
- Labeler code
- 0904
- Product ID
- 0904-7199_066e29d5-dcad-4017-a345-085432105a41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA200565
- Marketing category
- ANDA
- Marketing start
- 2014-04-17
- Substance
- PHENYTOIN
- Active strength
- 50 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phenytoin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYTOIN | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6158TKW0C5 |
| Rxcui | 1313885 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7199-07 | Phenytoin | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 4 |
| 0904-7199-07 | Phenytoin | 30 in 1 CARTON | TABLET, CHEWABLE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7199 | PHENYTOIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250125_08a9d26b-4419-43ec-98f3-43d4534c2e76.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 |
|---|
| 0904-7199-07 | 00904719907 | 30 BLISTER PACK in 1 CARTON (0904-7199-07) / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 30 blister pack | 2014-04-17 | 0000-00-00 | No | No | Current |