Phenytoin
- Product NDC
- 60687-156
- 11-digit product format
- 606870156
- Labeler code
- 60687
- Product ID
- 60687-156_2397a208-617f-7289-e063-6394a90a37e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA200565
- Marketing category
- ANDA
- Marketing start
- 2015-12-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phenytoin
- Listing expiration
- 2026-12-31
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 |
|---|
| 60687-156-25 | Phenytoin | 30 in 1 BOX, UNIT-DOSE | TABLET, CHEWABLE | 30 | | 8 |
| 60687-156-95 | Phenytoin | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Phenytoin | ACTIVE INGREDIENT | 6158TKW0C5 | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| Phenytoin | ACTIVE MOIETY | 6158TKW0C5 | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| Lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| Saccharin sodium | INACTIVE INGREDIENT | SB8ZUX40TY | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-156 | PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241010_352007dd-0587-4597-8338-c13eda4c5d63.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 |
|---|
| 60687-156-25 | 60687015625 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-156-25) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (60687-156-95) | 30 blister pack | 2015-12-02 | 0000-00-00 | No | No | Current |
| 60687-156-95 | 60687015695 | 1 in 1 BLISTER PACK | | | | | | Historical |