Home NDC 72603-831 Telmisartan
Product NDC 72603-831
11-digit product format 726030831
Labeler code 72603
Product ID 72603-831_9c22a318-d1f2-4788-9331-66fed71ebf38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan
Dosage form TABLET
Route ORAL
Labeler NorthStar RxLLC
Application ANDA203986
Marketing category ANDA
Marketing start 2025-12-01
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 43 .
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 A203986-001 TELMISARTAN TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 A203986-002 TELMISARTAN TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 A203986-003 TELMISARTAN TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15
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.
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 2026-09-14 22:38:34 2026-08 A203986-001 TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203986-002 TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203986-003 TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203986-001 TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203986-002 TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203986-003 TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203986-001 TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203986-002 TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203986-003 TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203986-001 TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203986-002 TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203986-003 TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203986-001 TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203986-002 TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203986-003 TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203986-001 TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203986-002 TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203986-003 TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203986-001 TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203986-002 TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203986-003 TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203986-001 TELMISARTAN 20MG TABLET / ORAL AB 2025-01-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203986-002 TELMISARTAN 40MG TABLET / ORAL AB 2025-01-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203986-003 TELMISARTAN 80MG TABLET / ORAL AB 2025-01-15 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 · 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 72603-831-01 Telmisartan 30 in 1 CONTAINER TABLET 30 1
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 Sample Exclude flag Status 72603-831-01 72603083101 30 TABLET in 1 CONTAINER (72603-831-01) 30 tablet 2025-12-01 No No Current