FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
0615-8211
Requested package NDC
0615-8211-39
11-digit product format
006158211
Labeler code
0615
Product ID
0615-8211_d6c7e105-d289-4a17-a650-12b9f333f43e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
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
2021-12-31
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 packagepackage0615-82110615-8211-39DDiscontinued 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8211-390061582113930 TABLET in 1 BLISTER PACK (0615-8211-39) 30 tablet2018-04-060000-00-00NoNoCurrent