FDA.reportPublic FDA data

Benztropine Mesylate

Product NDC
0615-8223
Requested package NDC
0615-8223-39
11-digit product format
006158223
Labeler code
0615
Product ID
0615-8223_c7b0eaab-bce7-4133-85e9-6ec282c63e7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA040715
Marketing category
ANDA
Marketing start
2022-03-17
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
2027-12-31
Current FDA listing
Yes

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 packagepackage0615-82230615-8223-39DDiscontinued 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
A040715-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27
A040715-002BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27
A040715-003BENZTROPINE MESYLATEBENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040715-001AA
A040715-002AA
A040715-003AA

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 22:54:322026-06A040715-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2007-08-27a50c72e98297…
2026-08-01 22:54:322026-06A040715-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2007-08-27a50c72e98297…
2026-08-01 22:54:322026-06A040715-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2007-08-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040715-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A040715-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A040715-003AA1a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATEUnit Dose Solutions, Inc.53c02a89-012c-e724-e063-6294a90acc752026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC52bd605a-6a28-c2ec-e063-6294a90a83712026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC512ada3e-4b85-d989-e063-6394a90a9d542026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC5035534e-e15c-8f06-e063-6294a90a50032026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsbac9dfb7-aa09-4841-9e8f-cc41bb438fe22026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
BENZTROPINE MESYLATEBENZTROPINE MESYLATEDIRECT RX9b93035b-34d6-4084-ba73-5dea72f9d1242026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsdf0647b8-2aa7-4aa4-9ba3-82c28698e7c52026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
ndc (package): 0615-8223-39
ndc (product): 0615-8223
ndc11 (package): 00615822339
Benztropine MesylateBENZTROPINE MESYLATEAmerican Health Packagingb7f915a9-cd53-4a74-8ee5-35ee5c5c991e2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATEMajor Pharmaceuticals8b18b66c-2935-4304-8e20-ebf68dee5a1a2025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATEA-S Medication Solutions53b134eb-b341-4fe4-a3ca-90a7da0119742024-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATEBryant Ranch Prepack959363b8-6847-4f6e-9957-6254febb085c2023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715
Benztropine MesylateBENZTROPINE MESYLATEEndo USA, Inc.c19664aa-a797-4192-b5f3-e906a7cac0482022-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040715
application number: ANDA040715

Additional Listing Data#

Finished product
Yes
Brand name base
Benztropine Mesylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZTROPINE MESYLATE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WMJ8TL7510Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
885213Internal RxNorm lookup
885219Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
df0647b8-2aa7-4aa4-9ba3-82c28698e7c5Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8223-39Benztropine Mesylate30 in 1 BLISTER PACKTABLET3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8223BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC20230504_bac9dfb7-aa09-4841-9e8f-cc41bb438fe2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSNdf0647b8-2aa7-4aa4-9ba3-82c28698e7c510
885213benztropine mesylate 1 MG Oral TabletPSNdf0647b8-2aa7-4aa4-9ba3-82c28698e7c510
885219benztropine mesylate 0.5 MG Oral TabletSCDdf0647b8-2aa7-4aa4-9ba3-82c28698e7c510
885213benztropine mesylate 1 MG Oral TabletSCDdf0647b8-2aa7-4aa4-9ba3-82c28698e7c510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8223-390061582233930 TABLET in 1 BLISTER PACK (0615-8223-39) 30 tablet2023-04-11NoNoCurrent