NDC 0071-0007

Dilantin Infatabs

Phenytoin

Dilantin Infatabs is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Parke-davis Div Of Pfizer Inc. The primary component is Phenytoin.

• Product ID: 0071-0007_26d317c7-7321-4ade-ad3e-746b11d1dfc5
• NDC: 0071-0007
• Product Type: Human Prescription Drug
• Proprietary Name: Dilantin Infatabs
• Generic Name: Phenytoin
• Dosage Form: Tablet, Chewable
• Route of Administration: ORAL
• Marketing Start Date: 1979-02-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA084427
• Labeler Name: Parke-Davis Div of Pfizer Inc
• Substance Name: PHENYTOIN
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0071-0007-24

100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24)

• Marketing Start Date: 1979-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0071-0007-24 [00071000724]

Dilantin Infatabs TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA084427
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1979-02-26

NDC 0071-0007-40 [00071000740]

Dilantin Infatabs TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA084427
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1979-02-26

Drug Details

Active Ingredients

Ingredient	Strength
PHENYTOIN	50 mg/1

OpenFDA Data

• SPL SET ID: ca119a89-2394-4d34-8078-cd1fa4e8e2f1
• Manufacturer:
  • Parke-Davis Div of Pfizer Inc
• UNII:
  • 6158TKW0C5
• RxNorm Concept Unique ID - RxCUI:
  • 1313887
  • 1313885
• UPC Code:
  • 0300710007246

Pharmacological Class

• Anti-epileptic Agent [EPC]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Cytochrome P450 1A2 Inducers [MoA]
• Cytochrome P450 2B6 Inducers [MoA]
• Cytochrome P450 2C8 Inducers [MoA]
• Cytochrome P450 2C19 Inducers [MoA]
• Cytochrome P450 2D6 Inducers [MoA]
• Cytochrome P450 3A Inducers [MoA]
• Cytochrome P450 2C9 Inducers [MoA]

NDC Crossover Matching brand name "Dilantin Infatabs" or generic name "Phenytoin"

NDC	Brand Name	Generic Name
0071-0007	Dilantin Infatabs	Phenytoin
0071-2214	Dilantin-125	Phenytoin
0121-0892	Phenytoin	Phenytoin
0378-3850	Phenytoin	Phenytoin
0615-7764	Phenytoin	Phenytoin
0904-7079	Phenytoin	Phenytoin
0904-7199	Phenytoin	Phenytoin
17856-0067	Phenytoin	Phenytoin
17856-4069	Phenytoin	Phenytoin
17856-4070	Phenytoin	Phenytoin
51079-129	Phenytoin	Phenytoin
51672-4069	Phenytoin	Phenytoin
51672-4146	Phenytoin	Phenytoin
59762-0531	Phenytoin	Phenytoin
0615-8260	Phenytoin Infatabs	Phenytoin
0615-8424	Phenytoin Infatabs	Phenytoin