Home NDC 54838-566-70 Lamivudine
Product NDC 54838-566
Requested package NDC 54838-566-70
11-digit product format 548380566
Labeler code 54838
Product ID 54838-566_b73db9be-cc57-417b-8545-43fbc355978d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA203564
Marketing category ANDA
Marketing start 2014-10-31
Marketing end 0000-00-00
Substance LAMIVUDINE
Active strength 10 mg/mL
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203564-001 LAMIVUDINE LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203564-001 AA
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 · 42 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 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203564-001 LAMIVUDINE 10MG/ML SOLUTION / ORAL AA 2014-10-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Lamivudine ACTIVE INGREDIENT 2T8Q726O95 LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 lamivudine ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 alcohol INACTIVE INGREDIENT 3K9958V90M LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 edetate disodium INACTIVE INGREDIENT 7FLD91C86K LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 methylparaben INACTIVE INGREDIENT A2I8C7HI9T LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 sucrose INACTIVE INGREDIENT C151H8M554 LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4 water INACTIVE INGREDIENT 059QF0KO0R LAMIVUDINE SOLUTION [SILARX PHARMACEUTICALS, INC] 4
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-566-70 54838056670 240 mL in 1 BOTTLE, PLASTIC (54838-566-70) 240 ml 2014-10-31 0000-00-00 No No Current