FDA.reportPublic FDA data

NDC 63850-0022-02 - Trihexyphenidyl Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63850-0022
Requested NDC
63850-0022-02
Package NDCs from labels
63850-0022-1, 63850-0022-2, 63850-0022-02
Manufacturer
Natco Pharma Limited | Natco Pharma Limited-Pharma Division
Effective date
2019-10-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRIHEXYPHENIDYL - Natco Pharma Limited | Natco Pharma Limited-Pharma DivisionNatco Pharma Limited | Natco Pharma Limited-Pharma Division2019-10-25Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63850-0022-1Trihexyphenidyl Hydrochloride100 in 1 BOTTLETABLET1002
63850-0022-2Trihexyphenidyl Hydrochloride1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63850-0022TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NATCO PHARMA LIMITED]2Current NDC, Legacy NDC, 2 package rows20191101_b7e4200c-feff-4537-aad1-cf9989fd8c14.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIHEXYPHENIDYL HYDROCHLORIDEACTIVE INGREDIENTAO61G82577TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1
TRIHEXYPHENIDYLACTIVE MOIETY6RC5V8B7POTRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.c25ea809-5bdf-4917-97f1-610059fbd0b72026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 905283
unii: AO61G82577
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.b60ef86c-b8b6-4530-baaf-d4671ce961af2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 905269
unii: AO61G82577
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEChartwell RX, LLCe8e2ac3b-80dc-4449-9365-2586d6d57e102026-07-17Warnings, Adverse reactionsExact identifier
unii: AO61G82577
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.86a65e8a-10f4-4f12-8e65-2edf398daeaa2026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 905269
unii: AO61G82577
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.3e71b957-9495-4583-8f00-99eac715ff852026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 905283
unii: AO61G82577
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.3ed3cdf1-1745-4c6f-bb90-fb7d9471270d2026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 905283
unii: AO61G82577
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEBionpharma Inc.4d4d473e-4f84-43e7-bb17-49e8dc1e97fd2025-07-02Warnings, Adverse reactionsExact identifier
application number: ANDA091630
rxcui: 905283
rxcui: 905269
unii: AO61G82577
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma9036c9f0-6d2d-4d0f-a20e-e36f9be228f72024-11-19Warnings, Adverse reactionsExact identifier
unii: AO61G82577
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEActavis Pharma, Inc.a44d7803-164d-4a67-9356-581c45de85962024-02-02Warnings, Adverse reactionsExact identifier
rxcui: 905283
rxcui: 905269
unii: AO61G82577
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.9040cb3b-13d2-e46d-e053-2a95a90ae9e62023-09-26Warnings, Adverse reactionsExact identifier
rxcui: 905283
rxcui: 905269
unii: AO61G82577
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEAkorn294cd88d-d9e8-4938-b4be-c3adc4a35de02022-06-21Warnings, Adverse reactionsExact identifier
unii: AO61G82577
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDENatco Pharma Limitedb7e4200c-feff-4537-aad1-cf9989fd8c142019-10-25Warnings, Adverse reactionsExact identifier
application number: ANDA091630
ndc (package): 63850-0022-2
ndc (package): 63850-0022-1
ndc (package): 63850-0021-2
ndc (package): 63850-0021-3
ndc (package): 63850-0021-1
ndc (product): 63850-0022
ndc (product): 63850-0021
ndc11 (package): 63850002202
rxcui: 905283
rxcui: 905269
spl id: 2b77cfd6-ad8a-4cbf-a22c-eb69e7a8548c
spl set id: b7e4200c-feff-4537-aad1-cf9989fd8c14
unii: AO61G82577
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDENovitium Pharma LLC83608c13-509d-448b-8559-5f5e8a9a0d752019-01-28Warnings, Adverse reactionsExact identifier
rxcui: 905283
rxcui: 905269
unii: AO61G82577

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.