FDA.reportPublic FDA data

TRIHEXYPHENIDYL HYDROCHLORIDE

Product NDC
70954-211
11-digit product format
709540211
Labeler code
70954
Product ID
70954-211_83608c13-509d-448b-8559-5f5e8a9a0d75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIHEXYPHENIDYL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Novitium Pharma LLC
Application
ANDA040254
Marketing category
ANDA
Marketing start
2019-01-28
Substance
TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRIHEXYPHENIDYL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIHEXYPHENIDYL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAO61G82577
Rxcui905269, 905283

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca4f09e5-cb3a-0be2-bbd8-d34d4562fedaProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-211-10TRIHEXYPHENIDYL HYDROCHLORIDE100 in 1 BOTTLETABLET1001
70954-211-20TRIHEXYPHENIDYL HYDROCHLORIDE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-211-10EA - Each70954-211216a71da-8038-4d06-a6fa-ce370949d0c112019-08-06
70954-211-20EA - Each70954-2115082d066-a764-40e9-bd63-3bed55f7591c12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-211TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NOVITIUM PHARMA LLC]1Current NDC, Legacy NDC, 2 package rows20190321_83608c13-509d-448b-8559-5f5e8a9a0d75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905283trihexyphenidyl HCl 5 MG Oral TabletPSNc25ea809-5bdf-4917-97f1-610059fbd0b712
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCDc25ea809-5bdf-4917-97f1-610059fbd0b712
905269trihexyphenidyl HCl 2 MG Oral TabletPSN9040cb3b-13d2-e46d-e053-2a95a90ae9e66
905283trihexyphenidyl HCl 5 MG Oral TabletPSN9040cb3b-13d2-e46d-e053-2a95a90ae9e66
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCD9040cb3b-13d2-e46d-e053-2a95a90ae9e66
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCD9040cb3b-13d2-e46d-e053-2a95a90ae9e66
905269trihexyphenidyl HCl 2 MG Oral TabletPSN83608c13-509d-448b-8559-5f5e8a9a0d751
905283trihexyphenidyl HCl 5 MG Oral TabletPSN83608c13-509d-448b-8559-5f5e8a9a0d751
905269trihexyphenidyl hydrochloride 2 MG Oral TabletSCD83608c13-509d-448b-8559-5f5e8a9a0d751
905283trihexyphenidyl hydrochloride 5 MG Oral TabletSCD83608c13-509d-448b-8559-5f5e8a9a0d751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-211-1070954021110100 TABLET in 1 BOTTLE (70954-211-10) 100 tablet2019-01-280000-00-00NoNoCurrent
70954-211-20709540211201000 TABLET in 1 BOTTLE (70954-211-20) 1000 tablet2019-01-280000-00-00NoNoCurrent