Home NDC 53746-293 Telmisartan
Product NDC 53746-293
11-digit product format 537460293
Labeler code 53746
Product ID 53746-293_77cf7b02-2f68-41ff-be0d-8ad569613822
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA204415
Marketing category ANDA
Marketing start 2016-09-25
Substance TELMISARTAN
Active strength 80 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204415-001 TELMISARTAN TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 A204415-002 TELMISARTAN TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 A204415-003 TELMISARTAN TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08
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 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204415-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-09-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204415-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204415-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-09-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Telmisartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TELMISARTAN 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U5SYW473RQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205304 Internal RxNorm lookup 205305 Internal RxNorm lookup 282755 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 53746-293-30 Telmisartan 30 in 1 BOTTLE TABLET 30 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-293 TELMISARTAN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 9 Current NDC, Legacy NDC, 1 package rows 20230809_bf2dca37-ce9c-40e4-8ad6-b8186aa7fed1.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53746-293-30 53746029330 30 TABLET in 1 BOTTLE (53746-293-30) 30 tablet 2016-09-25 0000-00-00 No No Current