NDC 0056-0474

SUSTIVA

Efavirenz

SUSTIVA is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Bristol-myers Squibb Pharma Company. The primary component is Efavirenz.

• Product ID: 0056-0474_092e0b1d-a576-4e96-bc9b-8d3f43cbb2df
• NDC: 0056-0474
• Product Type: Human Prescription Drug
• Proprietary Name: SUSTIVA
• Generic Name: Efavirenz
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 1998-09-17
• Marketing Category: NDA / NDA
• Application Number: NDA020972
• Labeler Name: Bristol-Myers Squibb Pharma Company
• Substance Name: EFAVIRENZ
• Active Ingredient Strength: 200 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: 2021-12-31

Packaging

NDC 0056-0474-92

90 CAPSULE, GELATIN COATED in 1 BOTTLE (0056-0474-92)

• Marketing Start Date: 1998-09-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0056-0474-92 [00056047492]

SUSTIVA CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA020972
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-09-17

Drug Details

Active Ingredients

Ingredient	Strength
EFAVIRENZ	200 mg/1

OpenFDA Data

• SPL SET ID: 32d6371e-ba56-4294-b732-6d43627c5c47
• Manufacturer:
  • Bristol-Myers Squibb Pharma Company
• UNII:
  • JE6H2O27P8
• RxNorm Concept Unique ID - RxCUI:
  • 349477
  • 352143
  • 205292
  • 205290
  • 213390
  • 213392
• UPC Code:
  • 0300560474922
  • 0300560510309
  • 0300560470306

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 "SUSTIVA" or generic name "Efavirenz"

NDC	Brand Name	Generic Name
0056-0470	SUSTIVA	Efavirenz
0056-0474	SUSTIVA	efavirenz
0056-0510	SUSTIVA	efavirenz
70518-0482	SUSTIVA	SUSTIVA
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