Moexipril Hydrochloride

Product NDC
68462-208
11-digit product format
684620208
Labeler code
68462
Product ID
68462-208_66bb1c8f-1f66-4834-86a3-a387d076aa22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moexipril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090416
Marketing category
ANDA
Marketing start
2010-12-31
Substance
MOEXIPRIL HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090416-001MOEXIPRIL HYDROCHLORIDEMOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30
A090416-002MOEXIPRIL HYDROCHLORIDEMOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090416-001AB
A090416-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090416-001MOEXIPRIL HYDROCHLORIDE7.5MGTABLET / ORALAB2010-03-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A090416-002MOEXIPRIL HYDROCHLORIDE15MGTABLET / ORALAB2010-03-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090416-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090416-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090416-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090416-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090416-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090416-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090416-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090416-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090416-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090416-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090416-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090416-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090416-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090416-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090416-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090416-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090416-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090416-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090416-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090416-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090416-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090416-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090416-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090416-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090416-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090416-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090416-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090416-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090416-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090416-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090416-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090416-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090416-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090416-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090416-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090416-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090416-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090416-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090416-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090416-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Moexipril Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOEXIPRIL HYDROCHLORIDE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q1UMG3UH45Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1299896Internal RxNorm lookup
1299897Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
baac91ad-f8ee-4694-89f8-5c47a8eda39aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
af9cc3a2-6f01-38ca-6e6b-5199b2c3eeecProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-208-01Moexipril Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10012
68462-208-10Moexipril Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100012
68462-208-90Moexipril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-208-01EA - Each68462-208c8afd61e-56e7-4fde-b54c-49af64b6e2f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOEXIPRIL HYDROCHLORIDEACTIVE INGREDIENTQ1UMG3UH45MOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
MOEXIPRILATACTIVE MOIETYH3753190JSMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-208MOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11Current NDC, Legacy NDC, 3 package rows20240423_baac91ad-f8ee-4694-89f8-5c47a8eda39a.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moexipril HydrochlorideMOEXIPRIL HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAbaac91ad-f8ee-4694-89f8-5c47a8eda39a2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090416
application number: ANDA090416
ndc (product): 68462-208

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299896moexipril HCl 15 MG Oral TabletPSNbaac91ad-f8ee-4694-89f8-5c47a8eda39a12
1299897moexipril HCl 7.5 MG Oral TabletPSNbaac91ad-f8ee-4694-89f8-5c47a8eda39a12
1299896moexipril hydrochloride 15 MG Oral TabletSCDbaac91ad-f8ee-4694-89f8-5c47a8eda39a12
1299897moexipril hydrochloride 7.5 MG Oral TabletSCDbaac91ad-f8ee-4694-89f8-5c47a8eda39a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-208-0168462020801100 TABLET, FILM COATED in 1 BOTTLE (68462-208-01) 2010-12-310000-00-00NoNoCurrent
68462-208-10684620208101000 TABLET, FILM COATED in 1 BOTTLE (68462-208-10) 2010-12-310000-00-00NoNoCurrent
68462-208-906846202089090 TABLET, FILM COATED in 1 BOTTLE (68462-208-90) 2010-12-310000-00-00NoNoCurrent