Home NDC 31722-853 OLMESARTAN MEDOXOMIL
Product NDC 31722-853
11-digit product format 317220853
Labeler code 31722
Product ID 31722-853_35cb69e0-7e6c-d4ee-e063-6294a90ae48c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OLMESARTAN MEDOXOMIL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA205499
Marketing category ANDA
Marketing start 2025-05-23
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 1 .
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 A205499-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 A205499-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 A205499-003 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31
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 2026-02-19 14:30 UTC 2026-02 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205499-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2024-10-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205499-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2024-10-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205499-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2024-10-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 31722-853-30 OLMESARTAN MEDOXOMIL 30 in 1 BOTTLE TABLET, FILM COATED 30 1 31722-853-90 OLMESARTAN MEDOXOMIL 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-853 OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20250524_53b8d406-a4f3-46ee-9aec-d70f7d806876.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 · 1 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 31722-853-30 31722085330 30 TABLET, FILM COATED in 1 BOTTLE (31722-853-30) 2025-05-23 No No Current 31722-853-90 31722085390 90 TABLET, FILM COATED in 1 BOTTLE (31722-853-90) 2025-05-23 No No Current