Home NDC 0591-3293 Telmisartan
Product NDC 0591-3293
11-digit product format 005913293
Labeler code 0591
Product ID 0591-3293_2c14d148-0140-46db-9086-0927892572d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA078710
Marketing category ANDA
Marketing start 2014-01-08
Marketing end 2019-06-30
Substance TELMISARTAN
Active strength 40 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 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 0591-3293-15 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078710-001 TELMISARTAN TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 A078710-002 TELMISARTAN TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 A078710-003 TELMISARTAN TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TELMISARTAN TELMISARTAN Chartwell RX, LLC. beaaf383-730f-4411-b5e7-15c32b53a338 2025-12-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078710 application number: ANDA078710