FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
50090-4082
Requested package NDC
50090-4082-0
11-digit product format
500904082
Labeler code
50090
Product ID
50090-4082_2a5330d3-ea62-489c-9efb-623719d62d0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204713
Marketing category
ANDA
Marketing start
2017-05-15
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
1 mg/1
Pharmacologic classes
Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage50090-408250090-4082-0IInactivated by FDA2026-07-31

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204713-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE0.5MGTABLET / ORALAARS2015-04-14
A204713-002BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MGTABLET / ORALAARS2015-04-14
A204713-003BENZTROPINE MESYLATEBENZTROPINE MESYLATE2MGTABLET / ORALAARS2015-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204713-001AA
A204713-002AA
A204713-003AA

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 22:54:322026-06A204713-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAARS2015-04-14a50c72e98297…
2026-08-01 22:54:322026-06A204713-002BENZTROPINE MESYLATE1MGTABLET / ORALAARS2015-04-14a50c72e98297…
2026-08-01 22:54:322026-06A204713-003BENZTROPINE MESYLATE2MGTABLET / ORALAARS2015-04-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204713-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A204713-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A204713-003AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZTROPINE MESYLATEBENZTROPINE MESYLATEMarlex PHARMACEUTICAL, INC31bbcbfa-dc74-99e2-e063-6394a90aa6082025-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204713
application number: ANDA204713
BENZTROPINE MESYLATEBENZTROPINE MESYLATESUNRISE PHARMACEUTICAL, INC2c988462-ce77-4e99-b98e-8f6ad519e2952024-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204713
application number: ANDA204713

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2961cf47-535c-c402-c24d-0a9130269674Product name320251121
3f930a8b-cc65-fba9-e4ca-58b6abcea16bProduct name220220509

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4082-02023-01-30C16284748780-1f386c649-992a-0266-e053-dadaa90a7c1aBENZTROPINE MESYLATE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4082-0Benztropine Mesylate60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4082BENZTROPINE MESYLATE TABLET [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190205_ad06b8a4-e998-4e1e-95a8-2c08427e325a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885213benztropine mesylate 1 MG Oral TabletPSNad06b8a4-e998-4e1e-95a8-2c08427e325a2
885213benztropine mesylate 1 MG Oral TabletSCDad06b8a4-e998-4e1e-95a8-2c08427e325a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4082-05009040820060 TABLET in 1 BOTTLE (50090-4082-0) 60 tablet2019-01-240000-00-00NoNoCurrent