Home NDC 68462-201 Telmisartan
Product NDC 68462-201
11-digit product format 684620201
Labeler code 68462
Product ID 68462-201_7e08eda5-be87-4e09-ae4e-880a18aa7a0b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
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 · 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TELMISARTAN ACTIVE INGREDIENT U5SYW473RQ TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 TELMISARTAN ACTIVE MOIETY U5SYW473RQ TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 MEGLUMINE INACTIVE INGREDIENT 6HG8UB2MUY TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-201 TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] 11 Current NDC, Legacy NDC, 7 package rows 20240315_c6eb489d-2946-4c14-839f-d4af761ead31.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 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 ndc (product): 68462-201 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 68462-201-01 68462020101 100 TABLET in 1 BOTTLE (68462-201-01) 100 tablet 2014-07-07 0000-00-00 No No Current 68462-201-13 68462020113 3 BLISTER PACK in 1 CARTON (68462-201-13) / 10 TABLET in 1 BLISTER PACK 3 blister pack 2014-07-07 0000-00-00 No No Current 68462-201-30 68462020130 30 TABLET in 1 BOTTLE (68462-201-30) 30 tablet 2020-12-14 0000-00-00 No No Current 68462-201-78 68462020178 4 BLISTER PACK in 1 CARTON (68462-201-78) / 10 TABLET in 1 BLISTER PACK 4 blister pack 2020-12-14 0000-00-00 No No Current 68462-201-90 68462020190 90 TABLET in 1 BOTTLE (68462-201-90) 90 tablet 2024-03-07 No No Current