Dilantin Infatabs
- Product NDC
- 0071-0007
- 11-digit product format
- 000710007
- Labeler code
- 0071
- Product ID
- 0071-0007_80f0cff3-357e-4328-860e-bbd525d80e6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Parke-Davis Div of Pfizer Inc
- Application
- ANDA084427
- Marketing category
- ANDA
- Marketing start
- 1979-02-26
- 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
- Dilantin Infatabs
- 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, 1313887 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0071-0007-24 | Dilantin Infatabs | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 58 |
| 0071-0007-40 | Dilantin Infatabs | 100 in 1 BOX, UNIT-DOSE | TABLET, CHEWABLE | 100 | | 58 |
| 0071-0007-40 | Dilantin Infatabs | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 58 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENYTOIN | ACTIVE INGREDIENT | 6158TKW0C5 | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| PHENYTOIN | ACTIVE MOIETY | 6158TKW0C5 | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 24 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0071-0007 | DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC] | 55 | Current NDC, Legacy NDC, 3 package rows | 20250115_ca119a89-2394-4d34-8078-cd1fa4e8e2f1.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 |
|---|
| 0071-0007-24 | 00071000724 | 100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24) | | 1979-02-26 | 0000-00-00 | No | No | Current |
| 0071-0007-40 | 00071000740 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0071-0007-40) > 1 TABLET, CHEWABLE in 1 BLISTER PACK | 100 blister pack | 1979-02-26 | 0000-00-00 | No | No | Current |