Dicyclomine Hydrochloride

Product NDC
67296-2226
11-digit product format
672962226
Labeler code
67296
Product ID
67296-2226_5197d491-0afe-2fb9-e063-6294a90a4bf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217916
Marketing category
ANDA
Marketing start
2023-09-13
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
67296-2226-5Dicyclomine Hydrochloride56 in 1 BOTTLE, PLASTICTABLET561

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN5198641d-bba1-b053-e063-6394a90a592b1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD5198641d-bba1-b053-e063-6394a90a592b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2226-56729622260556 TABLET in 1 BOTTLE, PLASTIC (67296-2226-5) 56 tablet2023-09-13NoNoCurrent