Abacavir and Lamivudine

Product NDC: 33342-440
11-digit product format: 333420440
Labeler code: 33342
Product ID: 33342-440_42b22ad0-4838-43fd-9bf7-f22dafc7c352
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Abacavir and Lamivudine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA212663
Marketing category: ANDA
Marketing start: 2024-12-20
Substance: ABACAVIR SULFATE; LAMIVUDINE
Active strength: 600; 300 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: 2026-12-31
Current FDA listing: Yes

Related Records

UNII	Preferred term	Registry number	Matched term
J220T4J9Q2	ABACAVIR SULFATE	188062-50-2	ABACAVIR SULFATE
2T8Q726O95	LAMIVUDINE	134678-17-4	LAMIVUDINE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
33342-440-07	33342044007	30 TABLET, FILM COATED in 1 BOTTLE (33342-440-07)		2024-12-20	No	No	Historical
33342-440-14	33342044014	5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)	5 blister pack	2024-12-20	No	No	Historical
33342-440-98	33342044098	10 BLISTER PACK in 1 CARTON (33342-440-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)	10 blister pack	2024-12-20	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Abacavir and Lamivudine	Macleods Pharmaceuticals Limited	2025-03-03	Human Prescription Drug Label	2