Home NDC 72162-2438 Telmisartan
Product NDC 72162-2438
11-digit product format 721622438
Labeler code 72162
Product ID 72162-2438_21b34fc6-d86a-4018-aace-dc9d77f8aa54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA208605
Marketing category ANDA
Marketing start 2015-02-05
Substance TELMISARTAN
Active strength 20 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 A208605-001 TELMISARTAN TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 A208605-002 TELMISARTAN TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 A208605-003 TELMISARTAN TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25
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 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208605-002 TELMISARTAN 40MG TABLET / ORAL AB 2017-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208605-003 TELMISARTAN 80MG TABLET / ORAL AB 2017-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208605-001 TELMISARTAN 20MG TABLET / ORAL AB 2017-07-25 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 20 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 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 72162-2438-3 Telmisartan 30 in 1 BOTTLE TABLET 30 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2438 TELMISARTAN TABLET [BRYANT RANCH PREPACK] 100 Current NDC, 1 package rows 20241225_e2deff49-b75e-4aaa-8114-d5ea1e3a94a5.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 Bryant Ranch Prepack e2deff49-b75e-4aaa-8114-d5ea1e3a94a5 2024-12-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208605 application number: ANDA208605 ndc (product): 72162-2438 Telmisartan TELMISARTAN Bryant Ranch Prepack b4ae8694-2af4-4acb-8634-b40c1cb6fb41 2024-12-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208605 application number: ANDA208605 Telmisartan TELMISARTAN Bryant Ranch Prepack f13e0919-5ee2-4855-b7c8-c8ab423769dd 2024-12-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208605 application number: ANDA208605 Telmisartan TELMISARTAN Modavar Pharmaceuticals LLC a075633a-2a2a-4e88-8ede-b49a3920a16c 2023-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208605 application number: ANDA208605 Telmisartan TELMISARTAN Cadila Pharmaceuticals Limited 353fcb30-2fa7-4ff1-8a18-26f3ec279d00 2023-08-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208605 application number: ANDA208605
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2438-3 72162243803 30 TABLET in 1 BOTTLE (72162-2438-3) 30 tablet 2024-12-23 No No Current