FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
50090-4772
11-digit product format
500904772
Labeler code
50090
Product ID
50090-4772_c47669cc-ed22-4780-804f-d5859d01dff9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209222
Marketing category
ANDA
Marketing start
2017-12-24
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10; 40 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
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209222-001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-22
A209222-002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-22
A209222-003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-22
A209222-004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209222-001AB
A209222-002AB
A209222-003AB
A209222-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209222-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209222-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209222-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209222-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-12-22d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209222-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209222-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209222-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209222-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209222-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209222-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209222-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209222-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209222-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209222-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209222-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209222-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209222-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209222-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209222-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209222-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209222-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209222-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209222-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209222-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209222-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209222-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209222-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209222-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209222-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209222-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209222-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209222-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209222-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209222-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209222-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209222-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209222-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209222-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209222-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209222-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209222-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209222-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209222-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209222-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe and Simvastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1
SIMVASTATIN40 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ce219a2-1eeb-4ece-bb87-3810e593ca51Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4772-02023-02-07C16284748780-1f386c64a-417b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral use Initial U.S. Approval: 2004
50090-4772-02023-01-30C16284748780-1f386c64a-417b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4772-0Ezetimibe and Simvastatin90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4772-0EA - Each50090-477233fd0721-7f35-4f61-bc3a-2c1b2cad54ac12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4772EZETIMIBE AND SIMVASTATIN TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20230208_2ce219a2-1eeb-4ece-bb87-3810e593ca51.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 SIMVASTATINA-S Medication Solutions2ce219a2-1eeb-4ece-bb87-3810e593ca512026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209222
application number: ANDA209222
ndc (product): 50090-4772
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAscend Laboratories, LLCc90e8c96-e130-42d7-bf0d-5833652e40d52025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209222
application number: ANDA209222

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN2ce219a2-1eeb-4ece-bb87-3810e593ca517
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD2ce219a2-1eeb-4ece-bb87-3810e593ca517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4772-05009047720090 TABLET in 1 BOTTLE (50090-4772-0) 90 tablet2019-12-020000-00-00NoNoCurrent