Home NDC 68788-8441-9 telmisartan
Product NDC 68788-8441
Requested package NDC 68788-8441-9
11-digit product format 687888441
Labeler code 68788
Product ID 68788-8441_1d39e994-31ef-48a1-bf0e-229117cc9a87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name telmisartan
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA205150
Marketing category ANDA
Marketing start 2023-05-02
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A205150-001 TELMISARTAN TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 A205150-002 TELMISARTAN TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 A205150-003 TELMISARTAN TELMISARTAN 80MG TABLET / ORAL AB RS 2015-10-30
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 · 132 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 2026-10-15 13:18:30 2026-09 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB RS 2015-10-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB RS 2015-10-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB RS 2015-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB RS 2015-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB RS 2015-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB RS 2015-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB RS 2015-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205150-002 TELMISARTAN 40MG TABLET / ORAL AB 2015-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205150-003 TELMISARTAN 80MG TABLET / ORAL AB 2015-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205150-001 TELMISARTAN 20MG TABLET / ORAL AB 2015-10-30 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base telmisartan
Listing expiration 2027-12-31 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 68788-8441-3 telmisartan 30 in 1 BOTTLE TABLET 30 3 68788-8441-6 telmisartan 60 in 1 BOTTLE TABLET 60 3 68788-8441-9 telmisartan 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8441 TELMISARTAN TABLET [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 3 package rows 20240816_f6da5155-9c26-46bb-bc0f-ece4ea21405f.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. 09d31eee-cd22-4918-a889-3eb4d2969525 2026-06-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205150 application number: ANDA205150 telmisartan TELMISARTAN Bryant Ranch Prepack 32489e86-0432-4d74-92f6-15e7450f52fa 2025-04-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205150 application number: ANDA205150 telmisartan TELMISARTAN Bryant Ranch Prepack 44e810d4-cf04-41d3-bdf8-0681210a669f 2025-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205150 application number: ANDA205150 telmisartan TELMISARTAN Ascend Laboratories, LLC 29bddc43-2809-4e1f-ae35-2865e15e9bb6 2025-03-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205150 application number: ANDA205150 telmisartan TELMISARTAN Proficient Rx LP 593a53a4-91bc-4e4a-aeff-08fc2efe3dd4 2020-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205150 application number: ANDA205150
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8441-9 68788844109 90 TABLET in 1 BOTTLE (68788-8441-9) 90 tablet 2023-05-02 No No Current