FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
53808-0826
11-digit product format
538080826
Labeler code
53808
Product ID
53808-0826_9405fe87-9769-4bd3-a38c-1fe354a02d7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA040103
Marketing category
ANDA
Marketing start
2013-01-01
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
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0826IInactivated by FDA2026-07-31
excluded packagepackage53808-082653808-0826-1IInactivated 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
A040103-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE0.5MGTABLET / ORALAA1996-12-12
A040103-002BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MGTABLET / ORALAA1996-12-12
A040103-003BENZTROPINE MESYLATEBENZTROPINE MESYLATE2MGTABLET / ORALAA1996-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040103-001AA
A040103-002AA
A040103-003AA

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 22:54:322026-06A040103-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA1996-12-12a50c72e98297…
2026-08-01 22:54:322026-06A040103-002BENZTROPINE MESYLATE1MGTABLET / ORALAA1996-12-12a50c72e98297…
2026-08-01 22:54:322026-06A040103-003BENZTROPINE MESYLATE2MGTABLET / ORALAA1996-12-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040103-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A040103-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A040103-003AA1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC513b1f4c-d253-6ad7-e063-6394a90a1dab2026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040103
application number: ANDA040103
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC50c61b1d-49d6-37f2-e063-6294a90a05902026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040103
application number: ANDA040103
Benztropine MesylateBENZTROPINE MESYLATEScieGen Pharmaceuticals Inc1ead16a7-88ed-407d-b25a-0d9a1d9da5ef2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040103
application number: ANDA040103

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
53808-0826-12020-01-31C16284748780-19d75b9d0-7b7f-f424-e053-dadaa90a57ceBENZTROPINE MESYLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0826-1Benztropine Mesylate30 in 1 BLISTER PACKTABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
benztropineACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EBENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0826BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20140402_bb315aeb-1ddd-4b90-b84a-8566bb70a753.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSNbb315aeb-1ddd-4b90-b84a-8566bb70a7532
885219benztropine mesylate 0.5 MG Oral TabletSCDbb315aeb-1ddd-4b90-b84a-8566bb70a7532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0826-15380808260130 in 1 BLISTER PACKHistorical