FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
0615-7677
11-digit product format
006157677
Labeler code
0615
Product ID
0615-7677_a56bcb74-de50-4c37-9c79-dd33abe04687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA040103
Marketing category
ANDA
Marketing start
1996-12-12
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
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-7677DDiscontinued by firm2026-07-31
excluded packagepackage0615-76770615-7677-31DDiscontinued by firm2026-07-31
excluded packagepackage0615-76770615-7677-39DDiscontinued 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-7677-312021-03-17C16284748780-19d75b9d0-3a36-f424-e053-dadaa90a57ceBENZTROPINE MESYLATE TABLETS, USP
0615-7677-392021-03-17C16284748780-19d75b9d0-3a36-f424-e053-dadaa90a57ceBENZTROPINE MESYLATE TABLETS, USP
0615-7677-312020-01-31C16284748780-19d75b9d0-3a36-f424-e053-dadaa90a57ceBENZTROPINE MESYLATE TABLETS, USP
0615-7677-392020-01-31C16284748780-19d75b9d0-3a36-f424-e053-dadaa90a57ceBENZTROPINE MESYLATE TABLETS, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
POVIDONE K12INACTIVE INGREDIENT333AG72FWJBENZTROPINE MESYLATE TABLET BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4