Dicyclomine Hydrochloride

Product NDC
72162-2613
11-digit product format
721622613
Labeler code
72162
Product ID
72162-2613_7ac8b53c-ac1d-431b-bc77-08d7be1d7d45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040319
Marketing category
ANDA
Marketing start
2023-05-08
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991061

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
72162-2613-0Dicyclomine Hydrochloride1000 in 1 BOTTLECAPSULE1000100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2613-0EA - Each72162-2613b96f394f-1767-458a-b949-d0d365b48aff12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN21ec88b3-22c7-492b-bfb1-73d3f9852522100
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD21ec88b3-22c7-492b-bfb1-73d3f9852522100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2613-0721622613001000 CAPSULE in 1 BOTTLE (72162-2613-0) 1000 capsule2026-04-20NoNoHistorical