Home NDC 72606-002 TEMIXYS
Product NDC 72606-002
11-digit product format 726060002
Labeler code 72606
Product ID 72606-002_0732cedf-911f-4b66-b610-3790d1df6b9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamivudine and tenofovir disoproxil fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CELLTRION USA, INC.
Application NDA211284
Marketing category NDA
Marketing start 2018-11-16
Marketing end 0000-00-00
Substance LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 300 mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 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 72606-002-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N211284-001 TEMIXYS LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 300MG;300MG TABLET / ORAL RLD 2018-11-16
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL 2018-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD, RS 2018-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD, RS 2018-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD, RS 2018-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD, RS 2018-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL 2018-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL 2018-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL 2018-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211284-001 TEMIXYS 300MG;300MG TABLET / ORAL RLD 2018-11-16 cb3db0bc1861…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72606-002-01 72606000201 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72606-002-01) 2019-11-07 0000-00-00 No No Current