FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
69238-1158
Requested package NDC
69238-1158-3
11-digit product format
692381158
Labeler code
69238
Product ID
69238-1158_331b2e88-9d76-4e41-bca7-bcff0e206614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208831
Marketing category
ANDA
Marketing start
2017-11-21
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10; 80 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
2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208831-001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORAL2017-11-21
A208831-002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORAL2017-11-21
A208831-003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORAL2017-11-21
A208831-004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORAL2017-11-21

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
2026-08-01 22:54:322026-06A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-11-21a50c72e98297…
2026-08-01 22:54:322026-06A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-11-21a50c72e98297…
2026-08-01 22:54:322026-06A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-11-21a50c72e98297…
2026-08-01 22:54:322026-06A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-11-21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAmneal Pharmaceuticals NY LLC5ea3ca31-cfee-4978-8b7a-755986f6b0912025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208831
application number: ANDA208831
ndc (package): 69238-1158-3
ndc (product): 69238-1158
ndc11 (package): 69238115803

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe and Simvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1
SIMVASTATIN80 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
5ea3ca31-cfee-4978-8b7a-755986f6b091Available 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
69238-1158-3Ezetimibe and Simvastatin30 in 1 BOTTLETABLET3013
69238-1158-9Ezetimibe and Simvastatin90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1158-3EA - Each69238-11587a844803-8fc9-4f36-9f56-171e775370ad12018-01-12
69238-1158-9EA - Each69238-1158c6e5eb78-2639-44f7-87b7-904e2f4db9bd12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1158EZETIMIBE AND SIMVASTATIN TABLET [AMNEAL PHARMACEUTICALS NY LLC]13Current NDC, Legacy NDC, 2 package rows20250427_5ea3ca31-cfee-4978-8b7a-755986f6b091.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN5ea3ca31-cfee-4978-8b7a-755986f6b09113
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN5ea3ca31-cfee-4978-8b7a-755986f6b09113
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN5ea3ca31-cfee-4978-8b7a-755986f6b09113
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN5ea3ca31-cfee-4978-8b7a-755986f6b09113
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD5ea3ca31-cfee-4978-8b7a-755986f6b09113
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD5ea3ca31-cfee-4978-8b7a-755986f6b09113
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD5ea3ca31-cfee-4978-8b7a-755986f6b09113
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD5ea3ca31-cfee-4978-8b7a-755986f6b09113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1158-36923811580330 TABLET in 1 BOTTLE (69238-1158-3) 30 tablet2017-11-210000-00-00NoNoCurrent