FDA.reportPublic FDA data

NDC 50090-4697-01 - Finasteride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50090-4697
Requested NDC
50090-4697-01
Package NDCs from labels
50090-4697-0, 50090-4697-1, 50090-4697-2, 50090-4697-01
Manufacturer
A-S Medication Solutions
Effective date
2023-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Finasteride - A-S Medication SolutionsA-S Medication Solutions2023-08-10Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4697-02023-02-07These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
50090-4697-12023-02-07These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
50090-4697-22023-02-07These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
50090-4697-02023-01-30These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
50090-4697-12023-01-30These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992
50090-4697-22023-01-30These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets for oral use. Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4697-0Finasteride30 in 1 BOTTLETABLET, FILM COATED308
50090-4697-1Finasteride90 in 1 BOTTLETABLET, FILM COATED908
50090-4697-2Finasteride100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4697FINASTERIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20230811_5e69ea84-dc5a-4aac-9353-4920c6f7b3aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4697-0EA - Each50090-469784d85a35-e899-413f-bc51-4fdc66ff6cd412023-09-05
50090-4697-1EA - Each50090-46974110e646-92b0-408e-9148-0be01398ab9c12023-09-05
50090-4697-2EA - Each50090-46971d7b4a89-a37e-4045-b6c2-731f06e5889312023-09-05

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 100 of 105 · 2,085 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 15FIX9V2JP
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 15FIX9V2JP
FinasterideFINASTERIDEA-S Medication Solutions5e69ea84-dc5a-4aac-9353-4920c6f7b3aa2023-08-10Warnings, Adverse reactionsExact identifier
application number: ANDA204304
ndc (package): 50090-4697-2
ndc (package): 50090-4697-1
ndc (package): 50090-4697-0
ndc (product): 50090-4697
ndc11 (package): 50090469701
rxcui: 310346
spl id: 2bae8977-9b78-48c9-a22a-9ea0c4c5075c
spl set id: 5e69ea84-dc5a-4aac-9353-4920c6f7b3aa
unii: 57GNO57U7G
FinasterideFINASTERIDEDr. Reddy's Laboratories Limiteda4dd6d6c-c8c7-16a9-aa68-aa46283dfae12023-07-20Warnings, Adverse reactionsExact identifier
rxcui: 310346
unii: 57GNO57U7G
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
unii: 15FIX9V2JP
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
unii: 15FIX9V2JP
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
unii: 15FIX9V2JP
FinasterideFINASTERIDEProficient Rx LP196f7d23-ed90-46c2-ae34-615e6ec1650b2023-04-01Warnings, Adverse reactionsExact identifier
unii: 57GNO57U7G
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
unii: 15FIX9V2JP
FinasterideFINASTERIDEProficient Rx LPe31a5901-ef04-4515-bca4-79118a3f37972023-02-01Warnings, Adverse reactionsExact identifier
application number: ANDA204304
rxcui: 310346
unii: 57GNO57U7G
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
FinasterideFINASTERIDESun Pharmaceutical Industries, Inc.abd87058-923f-4767-986c-278201c0e6882022-11-23Warnings, Adverse reactionsExact identifier
unii: 57GNO57U7G
FinasterideFINASTERIDEAsclemed USA, Inc.b63af2cd-5c12-4977-bac4-95e1eae11e572022-10-12Warnings, Adverse reactionsExact identifier
unii: 57GNO57U7G
FinasterideFINASTERIDEProficient Rx LP870ab7fe-fff9-4348-b900-213c1cf05f8e2022-06-01Warnings, Adverse reactionsExact identifier
unii: 57GNO57U7G
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 15FIX9V2JP
FinasterideFINASTERIDEProficient Rx LPe9ea2f77-11c3-4dbf-bdc4-d1b0e74379902022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310346
unii: 57GNO57U7G
FinasterideFINASTERIDEAphena Pharma Solutions - Tennessee, LLC845cad9c-c50d-4c98-8df8-893d1241836a2022-03-03Warnings, Adverse reactionsExact identifier
application number: ANDA204304
rxcui: 310346
unii: 57GNO57U7G
FinasterideFINASTERIDEAsclemed USA, Inc.b2cac9e5-ea52-44b7-ae88-78e11a7329042022-01-17Warnings, Adverse reactionsExact identifier
unii: 57GNO57U7G
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS97e7ece8-a705-4988-ba52-6d3f115735212021-12-01WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 ChestnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS6a44f926-11b4-4bc4-8d5d-721a89c4f0cc2021-11-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.