Home NDC 33342-002 Lamivudine
Product NDC 33342-002
11-digit product format 333420002
Labeler code 33342
Product ID 33342-002_9e19f010-5f8a-4582-8d49-c385698d9996
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA090198
Marketing category ANDA
Marketing start 2019-05-02
Substance LAMIVUDINE
Active strength 300 mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], 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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090198-001 LAMIVUDINE LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 A090198-002 LAMIVUDINE LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lamivudine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMIVUDINE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2T8Q726O95 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199147 Internal RxNorm lookup 349491 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-002-07 Lamivudine 30 in 1 BOTTLE TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-002 LAMIVUDINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 4 Current NDC, Legacy NDC, 1 package rows 20221203_1be30bcc-2d9f-4afc-8f09-adc840b3f2d9.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 33342-002-07 33342000207 30 TABLET, FILM COATED in 1 BOTTLE (33342-002-07) 2019-05-02 0000-00-00 No No Current