NDC 0378-4105

Abacavir Sulfate

Abacavir Sulfate

Abacavir Sulfate 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 Abacavir Sulfate.

• Product ID: 0378-4105_2b1700b3-c2fe-4e96-a849-403d17b5fa2e
• NDC: 0378-4105
• Product Type: Human Prescription Drug
• Proprietary Name: Abacavir Sulfate
• Generic Name: Abacavir Sulfate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-06-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091294
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ABACAVIR SULFATE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0378-4105-91

1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2012-06-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-4105-91 [00378410591]

Abacavir Sulfate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091294
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-06-19

Drug Details

Active Ingredients

Ingredient	Strength
ABACAVIR SULFATE	300 mg/1

OpenFDA Data

• SPL SET ID: 5676d391-f9a4-44be-9604-954b3d8d0e2b
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • J220T4J9Q2
• RxNorm Concept Unique ID - RxCUI:
  • 242679
• UPC Code:
  • 0303784105917

Pharmacological Class

• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC Crossover Matching brand name "Abacavir Sulfate" or generic name "Abacavir Sulfate"

NDC	Brand Name	Generic Name
0378-4105	Abacavir Sulfate	abacavir sulfate
0904-6523	Abacavir Sulfate	Abacavir Sulfate
51079-204	Abacavir Sulfate	abacavir sulfate
53808-0627	Abacavir Sulfate	abacavir sulfate
60505-3583	Abacavir Sulfate	Abacavir Sulfate
70518-0640	Abacavir Sulfate	Abacavir Sulfate
64980-405	Abacavir	Abacavir Sulfate
65862-089	Abacavir	Abacavir Sulfate
68084-021	Abacavir	Abacavir Sulfate
49702-221	ZIAGEN	abacavir sulfate
49702-222	ZIAGEN	abacavir sulfate
53808-0811	ZIAGEN	abacavir sulfate