Abacavir and Lamivudine

Product NDC
35573-430
11-digit product format
355730430
Labeler code
35573
Product ID
35573-430_307f2ff8-c695-482a-88af-52a48e65c01b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir and Lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA090159
Marketing category
ANDA
Marketing start
2019-11-15
Marketing end
0000-00-00
Substance
ABACAVIR SULFATE; LAMIVUDINE
Active strength
600 mg/1; mg/1
Pharmacologic classes
Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-430-30EA - Each35573-4304a55ff77-4947-4632-b90a-13b538b9ba6812020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-430-30355730430301 BOTTLE in 1 CARTON (35573-430-30) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-11-150000-00-00NoNoCurrent