Dicyclomine Hydrochloride

Product NDC
72162-2612
11-digit product format
721622612
Labeler code
72162
Product ID
72162-2612_89e81d35-c960-44ae-ab6d-a62e401a4777
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040317
Marketing category
ANDA
Marketing start
2023-04-25
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2612-0Dicyclomine Hydrochloride1000 in 1 BOTTLETABLET1000100
72162-2612-1Dicyclomine Hydrochloride100 in 1 BOTTLETABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2612-0EA - Each72162-26124857fe31-3101-4f54-9f1a-dbc2f6c02b7712026-05-22
72162-2612-1EA - Each72162-26124ecc16d5-7da7-4ad2-afc9-a14ffe298e3812026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN5734fac5-893d-4afd-95a1-e7ab4fd1df3a100
991086dicyclomine hydrochloride 20 MG Oral TabletSCD5734fac5-893d-4afd-95a1-e7ab4fd1df3a100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2612-0721622612001000 TABLET in 1 BOTTLE (72162-2612-0) 1000 tablet2026-04-20NoNoHistorical
72162-2612-172162261201100 TABLET in 1 BOTTLE (72162-2612-1) 100 tablet2026-04-20NoNoHistorical