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United States · US · US:0378-4105_3ae56d4c-73b4-497f-bc93-554a247f2359
Abacavir Sulfate
Orange BookUNIISPLATC J05AF06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AF06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103784105911 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
J220T4J9Q2
ABACAVIR SULFATE
RxCUI 221052
Orange Book
A091294
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": "0378-4105_3ae56d4c-73b4-497f-bc93-554a247f2359",
"productndc": "0378-4105",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091294",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 300MG BASE",
"product_no": "001",
"approval_date": "Jun 18, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ABACAVIR SULFATE",
"proprietary_name": "Abacavir Sulfate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091294",
"marketing_category": "ANDA",
"nonproprietary_name": "abacavir sulfate",
"start_marketing_date": "20120619",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J05AF06.
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