FDA.reportPublic FDA data

BENZTROPINE MESYLATE

Product NDC
69315-136
Requested package NDC
69315-136-10
11-digit product format
693150136
Labeler code
69315
Product ID
69315-136_f61e0118-7898-42cf-9e27-e5f2dabe6ea4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA090168
Marketing category
ANDA
Marketing start
2012-11-28
Substance
BENZTROPINE MESYLATE
Active strength
.5 mg/1
Pharmacologic classes
Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A090168-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE0.5MGTABLET / ORALAA2012-11-28
A090168-002BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MGTABLET / ORALAA2012-11-28
A090168-003BENZTROPINE MESYLATEBENZTROPINE MESYLATE2MGTABLET / ORALAA2012-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090168-001AA
A090168-002AA
A090168-003AA

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 22:54:322026-06A090168-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA2012-11-28a50c72e98297…
2026-08-01 22:54:322026-06A090168-002BENZTROPINE MESYLATE1MGTABLET / ORALAA2012-11-28a50c72e98297…
2026-08-01 22:54:322026-06A090168-003BENZTROPINE MESYLATE2MGTABLET / ORALAA2012-11-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090168-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A090168-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A090168-003AA1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.241479dd-91bf-455a-80a1-1bb2d1c8156d2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090168
application number: ANDA090168
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.01688e6f-7b22-41bf-9a85-1c88d90f99b62026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090168
application number: ANDA090168
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.7430b584-2812-4af5-994a-33dd1afed4762026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090168
application number: ANDA090168
BENZTROPINE MESYLATEBENZTROPINE MESYLATELeading Pharma, LLCfe002ec4-07cb-41ca-a58c-33b3a86821012021-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090168
application number: ANDA090168
ndc (package): 69315-136-10
ndc (product): 69315-136
ndc11 (package): 69315013610
BENZTROPINE MESYLATEBENZTROPINE MESYLATEAphena Pharma Solutions - Tennessee, LLCf82c6455-f36b-49d7-881e-6601d513d8462021-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090168
application number: ANDA090168
BENZTROPINE MESYLATEBENZTROPINE MESYLATEProficient Rx LPc1044563-2bd2-4f43-a951-25d083b1c6792019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090168
application number: ANDA090168

Additional Listing Data#

Finished product
Yes
Brand name base
BENZTROPINE MESYLATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZTROPINE MESYLATE.5 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
885209Internal RxNorm lookup
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
fe002ec4-07cb-41ca-a58c-33b3a8682101Available 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
69315-136-01BENZTROPINE MESYLATE100 in 1 BOTTLETABLET1008
69315-136-10BENZTROPINE MESYLATE1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-136-01EA - Each69315-136035b4c84-17e4-48a5-8d39-49ece51cd71812016-06-14
69315-136-10EA - Each69315-136588b637e-a3c4-472f-ba93-ae676a91971212016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-136BENZTROPINE MESYLATE TABLET [LEADING PHARMA, LLC]8Current NDC, Legacy NDC, 2 package rows20211123_fe002ec4-07cb-41ca-a58c-33b3a8682101.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSN241479dd-91bf-455a-80a1-1bb2d1c8156d14
885219benztropine mesylate 0.5 MG Oral TabletSCD241479dd-91bf-455a-80a1-1bb2d1c8156d14
885219benztropine mesylate 0.5 MG Oral TabletPSNfe002ec4-07cb-41ca-a58c-33b3a86821018
885213benztropine mesylate 1 MG Oral TabletPSNfe002ec4-07cb-41ca-a58c-33b3a86821018
885209benztropine mesylate 2 MG Oral TabletPSNfe002ec4-07cb-41ca-a58c-33b3a86821018
885219benztropine mesylate 0.5 MG Oral TabletSCDfe002ec4-07cb-41ca-a58c-33b3a86821018
885213benztropine mesylate 1 MG Oral TabletSCDfe002ec4-07cb-41ca-a58c-33b3a86821018
885209benztropine mesylate 2 MG Oral TabletSCDfe002ec4-07cb-41ca-a58c-33b3a86821018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-136-10693150136101000 TABLET in 1 BOTTLE (69315-136-10) 1000 tablet2016-05-150000-00-00NoNoCurrent