FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212663-001ABACAVIR SULFATE AND LAMIVUDINEABACAVIR SULFATE; LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2024-12-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2024-12-1984e616aacf4f…
2026-08-18 06:07:402026-07A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2024-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2024-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2024-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2024-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2024-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2024-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2024-12-1903ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212663-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2024-12-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212663-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212663-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212663-001AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Abacavir and Lamivudine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABACAVIR SULFATE600 mg/1
LAMIVUDINE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J220T4J9Q2Internal UNII lookup
2T8Q726O95Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
602393Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d36624c8-d773-4f99-81fc-433fae17feb3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aaa99659-c62c-7281-d402-9590409850c2Product name620260128
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8eProduct name820250626
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
3832141c-c294-474a-9473-1052c891450eProduct name220230105
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47eProduct name120190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68Product name320190627
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1Product name720181210
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
e1e3cf65-28b8-ebf3-c11f-d11a82e0862aProduct name420180604
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
c873f14e-2add-4d53-b9b3-bf775efd3702Product name120150325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-440-02Abacavir and Lamivudine6 in 1 BLISTER PACKTABLET, FILM COATED62
33342-440-07Abacavir and Lamivudine30 in 1 BOTTLETABLET, FILM COATED302
33342-440-14Abacavir and Lamivudine5 in 1 CARTONTABLET, FILM COATED52
33342-440-98Abacavir and Lamivudine10 in 1 CARTONTABLET, FILM COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-440ABACAVIR AND LAMIVUDINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, 4 package rows20250305_d36624c8-d773-4f99-81fc-433fae17feb3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abacavir and LamivudineABACAVIR AND LAMIVUDINEMacleods Pharmaceuticals Limitedd36624c8-d773-4f99-81fc-433fae17feb32025-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212663
application number: ANDA212663
ndc (product): 33342-440

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602393abacavir sulfate 600 MG / lamiVUDine 300 MG Oral TabletPSNd36624c8-d773-4f99-81fc-433fae17feb32
602393abacavir 600 MG / lamivudine 300 MG Oral TabletSCDd36624c8-d773-4f99-81fc-433fae17feb32
602393abacavir (as abacavir sulfate) 600 MG / lamivudine 300 MG Oral TabletSYd36624c8-d773-4f99-81fc-433fae17feb32
602393abacavir 600 MG / 3TC 300 MG Oral TabletSYd36624c8-d773-4f99-81fc-433fae17feb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-440-02333420440026 in 1 BLISTER PACKHistorical
33342-440-073334204400730 TABLET, FILM COATED in 1 BOTTLE (33342-440-07) 2024-12-20NoNoCurrent
33342-440-14333420440145 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02) 5 blister pack2024-12-20NoNoCurrent
33342-440-983334204409810 BLISTER PACK in 1 CARTON (33342-440-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02) 10 blister pack2024-12-20NoNoCurrent