FDA.reportPublic FDA data

Application 200292

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET;ORAL5MGNoNo
002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET;ORAL10MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200292-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31
A200292-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A200292-001AB
A200292-002AB

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 22:54:322026-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31a50c72e98297…
2026-08-01 22:54:322026-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200292-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A200292-002AB1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.41c095b6-acd9-4627-a813-bbca7ecafee52026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 70518-1666
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC48178cb4-4fee-47c0-88e9-a4f017f1f4482025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC042a59ea-131a-4806-b0f4-2f791d4414e22025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 43547-276
ndc (product): 43547-275
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_Rx93dddf28-094b-dd8c-e053-2995a90a63e92025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 72189-031
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirectRxcb1b3ed1-6e68-08e2-e053-2995a90a68c42025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 72189-265
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackc26d9bf3-e148-48bb-8f4f-e8c73804b3112023-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 71335-0900
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions5d46ef3c-0dee-4389-a2d5-997ea83428172023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 50090-3537

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
50090-1287donepezil hydrochloridedonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-3537donepezil hydrochloridedonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-3537donepezil hydrochloridedonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-3537donepezil hydrochloridedonepezil hydrochlorideA-S Medication SolutionsANDACurrent
67046-144donepezil hydrochloridedonepezil hydrochlorideContract Pharmacy Services-PAANDACurrent
68071-1523donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1523donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1523donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1523donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1572donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, IANDACurrent
68071-1572donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1572donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1700donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,InANDACurrent
68071-1700donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1700donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3396donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3396donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3396donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-7732donepezil hydrochloridedonepezil hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7732donepezil hydrochloridedonepezil hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7732donepezil hydrochloridedonepezil hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0900donepezil hydrochloridedonepezil hydrochlorideBryant Ranch PrepackANDACurrent
71335-0900donepezil hydrochloridedonepezil hydrochlorideBryant Ranch PrepackANDACurrent
71335-0900donepezil hydrochloridedonepezil hydrochlorideBryant Ranch PrepackANDACurrent
72189-031DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_RxANDACurrent
72189-031DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_RxANDACurrent
72189-031DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_RxANDACurrent
72189-031DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_RxANDACurrent
72189-265DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirectRxANDACurrent