NDC 65862-104

Efavirenz

Efavirenz

Efavirenz is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Efavirenz.

• Product ID: 65862-104_33ce13f3-f7d1-4b6e-93e7-b8aa106d5f9b
• NDC: 65862-104
• Product Type: Human Prescription Drug
• Proprietary Name: Efavirenz
• Generic Name: Efavirenz
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078064
• Labeler Name: Aurobindo Pharma Limited
• Substance Name: EFAVIRENZ
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 65862-104-10

3 BLISTER PACK in 1 CARTON (65862-104-10) > 10 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2017-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65862-104-30 [65862010430]

Efavirenz CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA078064
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-15

NDC 65862-104-10 [65862010410]

Efavirenz CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA078064
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-15

Drug Details

Active Ingredients

Ingredient	Strength
EFAVIRENZ	50 mg/1

OpenFDA Data

• SPL SET ID: 4c57ad7f-321a-46c8-851a-c895466eb8e1
• Manufacturer:
  • Aurobindo Pharma Limited
• UNII:
  • JE6H2O27P8
• RxNorm Concept Unique ID - RxCUI:
  • 205292
  • 205290
  • 205291
• UPC Code:
  • 0365862106308
  • 0365862105301
  • 0365862104106
  • 0365862105103

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