Home NDC 71209-080-04 Olmesartan Medoxomil
Product NDC 71209-080
Requested package NDC 71209-080-04
11-digit product format 712090080
Labeler code 71209
Product ID 71209-080_c8a58add-6c59-47ff-94e2-12d4e6513feb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan Medoxomil
Dosage form TABLET, COATED
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA210682
Marketing category ANDA
Marketing start 2025-01-01
Substance OLMESARTAN MEDOXOMIL
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 A210682-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 A210682-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 A210682-003 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08
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 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210682-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-11-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210682-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-11-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210682-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-11-08 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 Olmesartan Medoxomil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M97XTV3HD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349373 Internal RxNorm lookup 349401 Internal RxNorm lookup 349405 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 71209-080-01 Olmesartan Medoxomil 30 in 1 BOTTLE TABLET, COATED 30 6 71209-080-04 Olmesartan Medoxomil 90 in 1 BOTTLE TABLET, COATED 90 6 71209-080-10 Olmesartan Medoxomil 500 in 1 BOTTLE TABLET, COATED 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-080 OLMESARTAN MEDOXOMIL TABLET, COATED [CADILA PHARMACEUTICALS LIMITED] 6 Current NDC, 3 package rows 20250309_c5416a9f-1dcc-4851-bbc0-6664d22fc8fa.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71209-080-04 71209008004 90 TABLET, COATED in 1 BOTTLE (71209-080-04) 2025-01-01 No No Current