Home NDC 70518-2269 Olmesartan Medoxomil and Hydrochlorothiazide
Product NDC 70518-2269
11-digit product format 705182269
Labeler code 70518
Product ID 70518-2269_49f0288b-29b6-d4b6-e063-6394a90a22ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan Medoxomil and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA204233
Marketing category ANDA
Marketing start 2019-08-16
Substance OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength 40; 12.5 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-2269-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-2269-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-2269-0 557ba5c1ecfa…9c80585c8c6e…
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 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2017-04-24 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2017-04-24 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2017-04-24
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 · 129 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 2026-09-14 22:38:34 2026-08 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204233-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204233-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204233-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-04-24 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 Olmesartan Medoxomil and Hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 40 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M97XTV3HD Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403854 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 70518-2269-0 Olmesartan Medoxomil and Hydrochlorothiazide 90 in 1 BOTTLE, PLASTIC TABLET 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2269 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET [REMEDYREPACK INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241208_de815d64-b8d4-46a8-95b8-c230abe7f767.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Olmesartan Medoxomil and Hydrochlorothiazide OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE REMEDYREPACK INC. de815d64-b8d4-46a8-95b8-c230abe7f767 2026-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204233 application number: ANDA204233 ndc (product): 70518-2269 Olmesartan Medoxomil and Hydrochlorothiazide OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE Alembic Pharmaceuticals Inc. ca1a0aac-d81d-4c0a-91ea-cb719af772bf 2025-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204233 application number: ANDA204233 Olmesartan Medoxomil and Hydrochlorothiazide OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack e8a9dcaa-04e3-4f4e-a53d-42903e3da2d4 2024-06-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204233 application number: ANDA204233 Olmesartan Medoxomil and Hydrochlorothiazide OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE Alembic Pharmaceuticals Limited 8c65d555-8db8-40d9-be30-309ef09f19be 2023-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204233 application number: ANDA204233
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 70518-2269-0 70518226900 90 TABLET in 1 BOTTLE, PLASTIC (70518-2269-0) 90 tablet 2019-08-16 0000-00-00 No No Current