FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
51407-191
11-digit product format
514070191
Labeler code
51407
Product ID
51407-191_446023ff-25b4-2c12-e063-6294a90ad27e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA200909
Marketing category
ANDA
Marketing start
2017-04-26
Marketing end
2027-10-31
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10; 20 mg/1; mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51407-19151407-191-30DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200909-001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26
A200909-002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26
A200909-003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26
A200909-004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A200909-001AB
A200909-002AB
A200909-003AB
A200909-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200909-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200909-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200909-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200909-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200909-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200909-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200909-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200909-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200909-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200909-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200909-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200909-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200909-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200909-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe and Simvastatin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1
SIMVASTATIN20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EOR26LQQ24Internal UNII lookup
AGG2FN16EVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476345Internal RxNorm lookup
476349Internal RxNorm lookup
476350Internal RxNorm lookup
476351Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
88cd0e7b-e8dc-6125-e053-2a95a90aaa27Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
93a156a6-903b-1690-4dc3-a57adfaa8c1aProduct name920230322
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b249faa8-b784-47ef-8ad4-031ef248fa73Product name120200626
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-191-10Ezetimibe and Simvastatin1000 in 1 BOTTLETABLET10007
51407-191-30Ezetimibe and Simvastatin30 in 1 BOTTLETABLET307
51407-191-90Ezetimibe and Simvastatin90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-191-10EA - Each51407-191ff1dfae9-7f87-4dbb-8a85-0c29a42105c612019-06-19
51407-191-30EA - Each51407-1914b2b592a-9da9-4f88-a658-1c7cbf72d31312019-06-19
51407-191-90EA - Each51407-1912d534668-84ab-4dc5-830d-83676b8f014c12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-191EZETIMIBE AND SIMVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY]6Current NDC, Legacy NDC, 3 package rows20231215_88cd0e7b-e8dc-6125-e053-2a95a90aaa27.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINGolden State Medical Supply, Inc.88cd0e7b-e8dc-6125-e053-2a95a90aaa272025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200909
application number: ANDA200909
ndc (product): 51407-191
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINDr.Reddys Laboratories Inc023ca87a-1b04-8c17-dc4f-e2758b0771e22025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200909
application number: ANDA200909

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD88cd0e7b-e8dc-6125-e053-2a95a90aaa277

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-191-10514070191101000 TABLET in 1 BOTTLE (51407-191-10) 1000 tablet2019-04-292027-10-31NoNoCurrent
51407-191-305140701913030 TABLET in 1 BOTTLE (51407-191-30) 30 tablet2019-04-290000-00-00NoNoCurrent
51407-191-905140701919090 TABLET in 1 BOTTLE (51407-191-90) 90 tablet2019-04-292027-05-31NoNoCurrent