FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE

Product NDC
50228-342
Requested package NDC
50228-342-10
11-digit product format
502280342
Labeler code
50228
Product ID
50228-342_54de565a-a0f2-c621-e063-6394a90a9dae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA208465
Marketing category
ANDA
Marketing start
2026-05-19
Substance
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength
20; 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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208465-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALAB2026-03-31
A208465-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALAB2026-03-31
A208465-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALAB2026-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208465-001AB
A208465-002AB
A208465-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208465-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2026-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A208465-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2026-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A208465-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2026-03-3184e616aacf4f…
2026-08-18 06:07:402026-07A208465-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2026-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208465-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2026-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208465-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2026-03-31caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2026-03-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2026-03-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE25MG;40MGTABLET / ORALAB2026-03-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208465-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208465-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208465-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A208465-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208465-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208465-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208465-003AB1a50c72e98297…

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
IngredientStrength
OLMESARTAN MEDOXOMIL20 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M97XTV3HDInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403853Internal RxNorm lookup
403854Internal RxNorm lookup
403855Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52332190-2a12-d205-e063-6394a90ab7c5Available on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.574d2679-c036-fa12-e063-6394a90aef332026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208465
application number: ANDA208465
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals Inc52332190-2a12-d205-e063-6394a90ab7c52026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208465
application number: ANDA208465
ndc (package): 50228-342-10
ndc (product): 50228-342
ndc11 (package): 50228034210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50228-342-10502280342101000 TABLET, FILM COATED in 1 BOTTLE (50228-342-10) 2026-05-19NoNoCurrent