Home NDC 68180-603 Lamivudine
Product NDC 68180-603
11-digit product format 681800603
Labeler code 68180
Product ID 68180-603_ad5f0bef-21c0-46c1-989f-2f375e99bd3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA205217
Marketing category ANDA
Marketing start 2015-03-25
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68180-603-06 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68180-603-06 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68180-603-06 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68180-603-06 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68180-603-06 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68180-603-06 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68180-603-06 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68180-603-06 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68180-603-06 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68180-603-06 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68180-603-06 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68180-603-06 557ba5c1ecfa…9c80585c8c6e…
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 A205217-001 LAMIVUDINE LAMIVUDINE 150MG TABLET / ORAL 2014-12-18 A205217-002 LAMIVUDINE LAMIVUDINE 300MG TABLET / ORAL 2014-12-18
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 A205217-001 LAMIVUDINE 150MG TABLET / ORAL 2014-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205217-002 LAMIVUDINE 300MG TABLET / ORAL 2014-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205217-001 LAMIVUDINE 150MG TABLET / ORAL 2014-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205217-002 LAMIVUDINE 300MG TABLET / ORAL 2014-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205217-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-12-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205217-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-12-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-603-06 Lamivudine 30 in 1 BOTTLE TABLET, FILM COATED 30 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 POVIDONES INACTIVE INGREDIENT FZ989GH94E LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-603 LAMIVUDINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 15 Legacy NDC, 1 package rows 20240104_ff3b5265-f533-4332-a861-d8c9c1664ffd.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 68180-603-06 68180060306 30 TABLET, FILM COATED in 1 BOTTLE (68180-603-06) 2015-03-25 0000-00-00 No No Current