FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
63629-2135
Requested package NDC
63629-2135-1
11-digit product format
636292135
Labeler code
63629
Product ID
63629-2135_24a9c58a-ec96-4298-833d-1b9936249ce0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204713
Marketing category
ANDA
Marketing start
2017-05-15
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
2 mg/1
Pharmacologic classes
Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage63629-213563629-2135-1DDiscontinued by firm2026-07-31

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2135-1EA - Each63629-21358a66236b-6c47-4796-b619-52379e6e2bf012021-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2135-1636292135011000 TABLET in 1 BOTTLE, PLASTIC (63629-2135-1) 1000 tablet2021-03-100000-00-00NoNoCurrent