NDC 0071-2214

Dilantin-125

Phenytoin

Dilantin-125 is a Oral Suspension 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: 0071-2214_2290658d-13e5-43f6-805f-614c8baa613c
• NDC: 0071-2214
• Product Type: Human Prescription Drug
• Proprietary Name: Dilantin-125
• Generic Name: Phenytoin
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 1953-01-06
• Marketing Category: NDA / NDA
• Application Number: NDA008762
• Labeler Name: Parke-Davis Div of Pfizer Inc
• Substance Name: PHENYTOIN
• Active Ingredient Strength: 125 mg/5mL
• Pharm 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: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0071-2214-35

1 BOTTLE, PLASTIC in 1 CARTON (0071-2214-35) > 237 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2020-10-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0071-2214-20 [00071221420]

Dilantin-125 SUSPENSION

• Marketing Category: NDA
• Application Number: NDA008762
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1953-01-06

Drug Details

Active Ingredients

Ingredient	Strength
PHENYTOIN	125 mg/5mL

OpenFDA Data

• SPL SET ID: 051742b5-b0f0-44a5-8d31-3288527b0638
• Manufacturer:
  • Parke-Davis Div of Pfizer Inc
• UNII:
  • 6158TKW0C5
• RxNorm Concept Unique ID - RxCUI:
  • 1313884
  • 1313112
• UPC Code:
  • 0300712214208

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-125" or generic name "Phenytoin"

NDC	Brand Name	Generic Name
0071-2214	Dilantin-125	Phenytoin
0071-0007	Dilantin Infatabs	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