FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
62559-702
Requested package NDC
62559-702-30
11-digit product format
625590702
Labeler code
62559
Product ID
62559-702_61c89be9-44b0-42ca-bedd-1c0b65662757
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA208831
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
2023-03-31
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10 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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62559-70262559-702-30DDiscontinued by firm2026-07-31

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

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-702-30EA - Each62559-702701178ec-cefa-4b2f-bd53-0947c240dd1012018-10-11
62559-702-90EA - Each62559-702a9d8e571-7879-4d4c-b2d1-f0f2aa5f047412018-10-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSNfc205122-d66a-41cc-bfce-8e4c109f2f501
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCDfc205122-d66a-41cc-bfce-8e4c109f2f501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-702-306255907023030 TABLET in 1 BOTTLE (62559-702-30) 30 tablet2018-09-242022-07-31NoNoCurrent