FDA.reportPublic FDA data

ABACAVIR and LAMIVUDINE tablets, for oral use

Manufacturer
Zydus Lifesciences Limited
Effective date
2023-09-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:25:33

Label at a glance#

ProductAbacavir and lamivudine
Active ingredientABACAVIR SULFATE, LAMIVUDINE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1053-9

Abacavir and Lamivudine Tablets, 600 mg/300 mg

90 Tablets

Rx only

abacavir sulfate and lamivudine tablet
abacavir sulfate and lamivudine tablet

Abacavir Sulfate and Lamivudine Tablet:

Warning Card

abacavir sulfate and lamivudine tablet
abacavir sulfate and lamivudine tablet

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1053ABACAVIR AND LAMIVUDINE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20230928_3709b07b-a37d-4ffb-92fa-5c0dd9b973b7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-105370771-1053-3, 70771-1053-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ABACAVIR SULFATEJ220T4J9Q2ACTIM
LAMIVUDINE2T8Q726O95ACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C RED NO. 40WZB9127XOAIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE K30U725QWY32XIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208990-001ABACAVIR SULFATE AND LAMIVUDINEABACAVIR SULFATE; LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15c2088c7a36db…
2026-09-14 22:38:342026-08A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-1584e616aacf4f…
2026-08-18 06:07:402026-07A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-153f01610625f2…
2019-09-15 20:21 UTC2019-09A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208990-001ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGTABLET / ORAL2018-11-153a93d1ddd44b…

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
1737bc18-f893-414f-8500-902590b3bfb53709b07b-a37d-4ffb-92fa-5c0dd9b973b72025-08-23Exact identifier
spl set id: 3709b07b-a37d-4ffb-92fa-5c0dd9b973b7

Reported adverse events (FAERS/openFDA)#

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