NDC 70518-1013

Efavirenz

Efavirenz

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

• Product ID: 70518-1013_651f92f0-132a-7cad-e053-2991aa0a2ea9
• NDC: 70518-1013
• Product Type: Human Prescription Drug
• Proprietary Name: Efavirenz
• Generic Name: Efavirenz
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-02-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091471
• Labeler Name: REMEDYREPACK 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: 2019-12-31

Packaging

NDC 70518-1013-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1013-0)

• Marketing Start Date: 2018-02-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1013-0 [70518101300]

Efavirenz TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091471
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-02-12
• Marketing End Date: 2020-05-11

Drug Details

Active Ingredients

Ingredient	Strength
EFAVIRENZ	600 mg/1

OpenFDA Data

• SPL SET ID: 36868680-502d-46ec-a103-c455d200d227
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • JE6H2O27P8
• RxNorm Concept Unique ID - RxCUI:
  • 349477

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