Home NDC 71335-1723 Telmisartan
Product NDC 71335-1723
11-digit product format 713351723
Labeler code 71335
Product ID 71335-1723_2896ac53-432d-437e-88f3-03d92b0dca36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090032
Marketing category ANDA
Marketing start 2014-07-07
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 2027-12-31
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 A090032-001 TELMISARTAN TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 A090032-002 TELMISARTAN TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 A090032-003 TELMISARTAN TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07
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 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090032-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090032-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090032-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 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 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205305 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 71335-1723-1 Telmisartan 90 in 1 BOTTLE TABLET 90 104 71335-1723-2 Telmisartan 30 in 1 BOTTLE TABLET 30 104 71335-1723-3 Telmisartan 180 in 1 BOTTLE TABLET 180 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1723 TELMISARTAN TABLET [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 3 package rows 20240410_c55e4fe1-f04d-4995-a706-9f432fde57e4.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Telmisartan TELMISARTAN REMEDYREPACK INC. 91215664-6e19-4e04-9ae7-ab5664799426 2026-07-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090032 application number: ANDA090032 Telmisartan TELMISARTAN Bryant Ranch Prepack c55e4fe1-f04d-4995-a706-9f432fde57e4 2026-05-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090032 application number: ANDA090032 ndc (product): 71335-1723 Telmisartan TELMISARTAN Glenmark Pharmaceuticals Inc., USA c6eb489d-2946-4c14-839f-d4af761ead31 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090032 application number: ANDA090032 Telmisartan TELMISARTAN Preferred Pharmaceuticals Inc. bf8e95fa-d181-4b46-8609-497e14a73dc1 2025-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090032 application number: ANDA090032 Telmisartan TELMISARTAN NuCare Pharmaceuticals,Inc. a020e2a7-d1e7-8ae0-e053-2995a90abad3 2024-06-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090032 application number: ANDA090032
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 71335-1723-1 71335172301 90 TABLET in 1 BOTTLE (71335-1723-1) 90 tablet 2024-04-04 0000-00-00 No No Current 71335-1723-2 71335172302 30 TABLET in 1 BOTTLE (71335-1723-2) 30 tablet 2020-10-20 0000-00-00 No No Current 71335-1723-3 71335172303 180 TABLET in 1 BOTTLE (71335-1723-3) 180 tablet 2020-10-20 No No Current