Home NDC 50090-5489-0 Telmisartan
Product NDC 50090-5489
Requested package NDC 50090-5489-0
11-digit product format 500905489
Labeler code 50090
Product ID 50090-5489_1bb809ec-819e-437b-ac3e-db251ed587fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name telmisartan
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA202397
Marketing category ANDA
Marketing start 2014-07-07
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A202397-001 TELMISARTAN TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 A202397-002 TELMISARTAN TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 A202397-003 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 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202397-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202397-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202397-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202397-001 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5489-0 Telmisartan 90 in 1 BOTTLE, PLASTIC TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5489 TELMISARTAN TABLET [A-S MEDICATION SOLUTIONS] 2 Legacy NDC, 1 package rows 20210911_59bb2556-7add-49b5-8c04-eef5ff60c46a.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 · 3 matching rows.
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 50090-5489-0 50090548900 90 TABLET in 1 BOTTLE, PLASTIC (50090-5489-0) 90 tablet 2021-03-15 0000-00-00 No No Current