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United States · US · US:42385-962_e6dbfbf4-1917-4764-a6b2-e3da98aa5620
Abacavir and Lamivudine
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114238596218180 TABLET, FILM COATED in 1 BOTTLE (42385-962-18)
- ndc11423859623030 TABLET, FILM COATED in 1 BOTTLE (42385-962-30)
- ndc11423859629090 TABLET, FILM COATED in 1 BOTTLE (42385-962-90)
Annotations
UNII (FDA Substance ID)
J220T4J9Q2
ABACAVIR SULFATE
RxCUI 221052
Orange Book
A216332
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "J220T4J9Q2",
"rxcui": "221052",
"inchikey": "WMHSRBZIJNQHKT-FFKFEZPRSA-N",
"display_name": "ABACAVIR SULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4b286ec6-68a7-4ec0-af07-5a27ec9cb35d": {
"match": "brand_token",
"title": "ABACAVIR TABLET, FILM COATED [MAJOR PHARMACEUTICALS]",
"spl_version": "6",
"published_date": "2026-03-18"
}
},
"productid": "42385-962_e6dbfbf4-1917-4764-a6b2-e3da98aa5620",
"productndc": "42385-962",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216332",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 600MG BASE;300MG",
"product_no": "001",
"approval_date": "Jul 25, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ABACAVIR SULFATE; LAMIVUDINE",
"proprietary_name": "Abacavir and Lamivudine",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA216332",
"marketing_category": "ANDA",
"nonproprietary_name": "Abacavir and Lamivudine",
"start_marketing_date": "20220725",
"active_numerator_strength": "600; 300"
}Related drugs
Other records sharing ATC code J05AF.
- GBAbacavir 600mg / Lamivudine 300mg tabletsMilpharm Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsDr Reddy's Laboratories (UK) Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsSun Pharma UK Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsZentiva Pharma UK Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsLupin Healthcare (UK) Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsTeva UK Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsViatris UK Healthcare Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsA A H Pharmaceuticals Ltd
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