Abacavir and Lamivudine

Product NDC
65862-335
Requested package NDC
65862-335-99
11-digit product format
658620335
Labeler code
65862
Product ID
65862-335_7fbb109d-29d0-4439-b4ef-00c587cc6099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir and Lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090159
Marketing category
ANDA
Marketing start
2018-11-15
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-33565862-335-99UNFINISHEDActive or certified unfinished drug listing2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…

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
A090159-001ABACAVIR SULFATE AND LAMIVUDINEABACAVIR SULFATE; LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090159-001AB

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-1584e616aacf4f…
2026-08-18 06:07:402026-07A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-153f01610625f2…
2019-09-15 20:21 UTC2019-09A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090159-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORALAB2018-11-15f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090159-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A090159-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090159-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090159-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090159-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090159-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090159-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090159-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090159-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090159-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090159-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090159-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090159-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090159-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090159-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090159-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090159-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090159-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090159-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090159-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090159-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090159-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090159-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090159-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090159-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090159-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090159-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090159-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090159-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090159-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090159-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090159-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090159-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090159-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090159-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090159-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090159-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090159-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090159-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090159-001AB1f41ea6bd6efb…

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
deda1a24-2f51-4601-9881-347f47270940Available 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
65862-335-10Abacavir and Lamivudine10 in 1 BLISTER PACKTABLET, FILM COATED107
65862-335-10Abacavir and Lamivudine10 in 1 CARTONTABLET, FILM COATED107
65862-335-30Abacavir and Lamivudine30 in 1 BOTTLETABLET, FILM COATED307
65862-335-30Abacavir and Lamivudine1 in 1 CARTONTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-335-30EA - Each65862-335397b7e6c-8943-4a92-8aff-4224b4de1c8f12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-335ABACAVIR AND LAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 4 package rows20240521_deda1a24-2f51-4601-9881-347f47270940.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 LAMIVUDINEAurobindo Pharma Limiteddeda1a24-2f51-4601-9881-347f472709402024-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090159
application number: ANDA090159
ndc (product): 65862-335

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602393abacavir sulfate 600 MG / lamiVUDine 300 MG Oral TabletPSNdeda1a24-2f51-4601-9881-347f472709407
602393abacavir 600 MG / lamivudine 300 MG Oral TabletSCDdeda1a24-2f51-4601-9881-347f472709407
602393abacavir (as abacavir sulfate) 600 MG / lamivudine 300 MG Oral TabletSYdeda1a24-2f51-4601-9881-347f472709407
602393abacavir 600 MG / 3TC 300 MG Oral TabletSYdeda1a24-2f51-4601-9881-347f472709407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-335-99658620335991000 TABLET, FILM COATED in 1 BAG (65862-335-99)15-NOV-18Current