Phenytoin Infatabs
- Product NDC
- 0615-8424
- 11-digit product format
- 006158424
- Labeler code
- 0615
- Product ID
- 0615-8424_44fa2cc3-a26a-4e4d-9087-a196c69d9ca5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA084427
- Marketing category
- ANDA
- Marketing start
- 2021-11-23
- Marketing end
- 2026-11-30
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phenytoin Infatabs
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 |
|---|
| 0615-8424-39 | Phenytoin Infatabs | 30 in 1 BLISTER PACK | TABLET, CHEWABLE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8424 | PHENYTOIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240413_0d240b2b-bc5c-4989-a20b-54ed37a09a4f.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 |
|---|
| 0615-8424-39 | 00615842439 | 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39) | 2022-02-01 | 2026-11-30 | No | No | Current |