NDC 0378-2233

Efavirenz

Efavirenz

Efavirenz is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Efavirenz.

• Product ID: 0378-2233_20df0127-64fc-44b4-9d8d-13852a689c44
• NDC: 0378-2233
• Product Type: Human Prescription Drug
• Proprietary Name: Efavirenz
• Generic Name: Efavirenz
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-01-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091471
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: EFAVIRENZ
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-2233-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2233-93)

• Marketing Start Date: 2018-01-30
• Marketing End Date: 2023-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-2233-93 [00378223393]

Efavirenz TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091471
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-01-30

Drug Details

Active Ingredients

Ingredient	Strength
EFAVIRENZ	600 mg/1

OpenFDA Data

• SPL SET ID: 8172caa9-22bf-4be5-8cce-2e874e7c28e2
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • JE6H2O27P8
• RxNorm Concept Unique ID - RxCUI:
  • 349477
• UPC Code:
  • 0303782233933

Pharmacological Class

• Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Non-Nucleoside Analog [EXT]
• Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Cytochrome P450 3A Inducers [MoA]
• Cytochrome P450 2B6 Inducers [MoA]
• Cytochrome P450 2C9 Inhibitors [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]
• Cytochrome P450 3A4 Inhibitors [MoA]

NDC Crossover Matching brand name "Efavirenz" or generic name "Efavirenz"

NDC	Brand Name	Generic Name
0378-2233	Efavirenz	efavirenz
31722-504	Efavirenz	Efavirenz
42543-889	Efavirenz	Efavirenz
51407-382	Efavirenz	Efavirenz
64380-889	Efavirenz	Efavirenz
64980-406	Efavirenz	Efavirenz
64980-407	Efavirenz	Efavirenz
65862-049	Efavirenz	Efavirenz
65862-104	Efavirenz	Efavirenz
69097-301	Efavirenz	Efavirenz
70518-1100	Efavirenz	Efavirenz
70518-1013	Efavirenz	Efavirenz
65862-105	Efavirenz	Efavirenz
65862-106	Efavirenz	Efavirenz
65862-774	Efavirenz	Efavirenz
0056-0470	SUSTIVA	Efavirenz
0056-0474	SUSTIVA	efavirenz
0056-0510	SUSTIVA	efavirenz