FDA.reportPublic FDA data

ABACAVIR and LAMIVUDINE

Product NDC
31722-838
11-digit product format
317220838
Labeler code
31722
Product ID
31722-838_366cb4c4-0386-17b7-e063-6394a90a5fd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ABACAVIR and LAMIVUDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205412
Marketing category
ANDA
Marketing start
2025-04-16
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
A205412-001ABACAVIR SULFATE AND LAMIVUDINEABACAVIR SULFATE; LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2025-04-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A205412-001AB

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 22:38:342026-08A205412-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2025-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A205412-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2025-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205412-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2025-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205412-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2025-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205412-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2025-04-166a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205412-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2025-04-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205412-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A205412-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205412-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205412-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205412-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205412-001AB1a50c72e98297…

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
e8988924-c18c-4e91-ab79-2d84e72bfa0dAvailable 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
31722-838-30ABACAVIR and LAMIVUDINE1 in 1 CARTONTABLET, FILM COATED11
31722-838-30ABACAVIR and LAMIVUDINE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-838-30EA - Each31722-838837c1002-6ed1-4084-a7f5-9b64f9ec719512026-01-08

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 LAMIVUDINECamber Pharmaceuticals, Inc.e8988924-c18c-4e91-ab79-2d84e72bfa0d2025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205412
application number: ANDA205412
ndc (product): 31722-838

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602393abacavir sulfate 600 MG / lamiVUDine 300 MG Oral TabletPSNe8988924-c18c-4e91-ab79-2d84e72bfa0d1
602393abacavir 600 MG / lamivudine 300 MG Oral TabletSCDe8988924-c18c-4e91-ab79-2d84e72bfa0d1
602393abacavir (as abacavir sulfate) 600 MG / lamivudine 300 MG Oral TabletSYe8988924-c18c-4e91-ab79-2d84e72bfa0d1
602393abacavir 600 MG / 3TC 300 MG Oral TabletSYe8988924-c18c-4e91-ab79-2d84e72bfa0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-838-30317220838301 BOTTLE in 1 CARTON (31722-838-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-16NoNoCurrent