Home NDC 60219-1155-9 Ezetimibe and Simvastatin
Product NDC 60219-1155
Requested package NDC 60219-1155-9
11-digit product format 602191155
Labeler code 60219
Product ID 60219-1155_593a2d33-aa14-4056-9b63-52d59426f356
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
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208831-001 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-11-21 A208831-002 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-11-21 A208831-003 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-11-21 A208831-004 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-11-21
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-11-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-11-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-11-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-11-21 a50c72e98297…
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-1155 EZETIMIBE AND SIMVASTATIN TABLET [AMNEAL PHARMACEUTICALS NY LLC] 4 Legacy NDC 20250108_e515c269-0b34-4cca-970d-2efc7f7a15eb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60219-1155-9 60219115509 90 TABLET in 1 BOTTLE (60219-1155-9) 90 tablet 2017-11-21 0000-00-00 No No Current