Abacavir Sulfate

Product NDC: 0904-6523
11-digit product format: 009046523
Labeler code: 0904
Product ID: 0904-6523_6c34c695-fdbc-4884-a763-db18663333b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Abacavir Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA201570
Marketing category: ANDA
Marketing start: 2012-12-17
Marketing end: 0000-00-00
Substance: ABACAVIR SULFATE
Active strength: 300 mg/1
Pharmacologic classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J220T4J9Q2	ABACAVIR SULFATE	188062-50-2	ABACAVIR SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6523-04	00904652304	30 BLISTER PACK in 1 CARTON (0904-6523-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK	30 blister pack	2012-12-17	0000-00-00	No	No	Current
0904-6523-06	00904652306	50 BLISTER PACK in 1 CARTON (0904-6523-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK	50 blister pack	2012-12-17	0000-00-00	No	No	Current