abacavir and lamivudine

Generic: abacavir and lamivudine

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abacavir and lamivudine
Generic Name abacavir and lamivudine
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abacavir sulfate 600 mg/1, lamivudine 300 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-440
Product ID 33342-440_42b22ad0-4838-43fd-9bf7-f22dafc7c352
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212663
Listing Expiration 2026-12-31
Marketing Start 2024-12-20

Pharmacologic Class

Established (EPC)
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342440
Hyphenated Format 33342-440

Supplemental Identifiers

RxCUI
602393
UPC
0333342440075
UNII
J220T4J9Q2 2T8Q726O95
NUI
N0000175656 N0000175462 N0000009947

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name abacavir and lamivudine (source: ndc)
Generic Name abacavir and lamivudine (source: ndc)
Application Number ANDA212663 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-440-07)
  • 5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)
  • 10 BLISTER PACK in 1 CARTON (33342-440-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)
source: ndc

Packages (3)

33342-440-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-440-07) 33342-440-14 5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02) 33342-440-98 10 BLISTER PACK in 1 CARTON (33342-440-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)

Ingredients (2)

abacavir sulfate (600 mg/1) lamivudine (300 mg/1)

Linked Drug Pages (1)

Abacavir and Lamivudine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42b22ad0-4838-43fd-9bf7-f22dafc7c352", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "upc": ["0333342440075"], "unii": ["J220T4J9Q2", "2T8Q726O95"], "rxcui": ["602393"], "spl_set_id": ["d36624c8-d773-4f99-81fc-433fae17feb3"], "pharm_class_epc": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-440-07)", "package_ndc": "33342-440-07", "marketing_start_date": "20241220"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (33342-440-14)  / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)", "package_ndc": "33342-440-14", "marketing_start_date": "20241220"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-440-98)  / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)", "package_ndc": "33342-440-98", "marketing_start_date": "20241220"}], "brand_name": "Abacavir and Lamivudine", "product_id": "33342-440_42b22ad0-4838-43fd-9bf7-f22dafc7c352", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "33342-440", "generic_name": "Abacavir and Lamivudine", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abacavir and Lamivudine", "active_ingredients": [{"name": "ABACAVIR SULFATE", "strength": "600 mg/1"}, {"name": "LAMIVUDINE", "strength": "300 mg/1"}], "application_number": "ANDA212663", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20261231"}