Dicyclomine hydrochloride

Product NDC
67296-2158
11-digit product format
672962158
Labeler code
67296
Product ID
67296-2158_45d267f6-9cad-b5b1-e063-6294a90a982f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA217531
Marketing category
ANDA
Marketing start
2022-08-23
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine hydrochloride
Listing expiration
2026-12-31

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
67296-2158-3Dicyclomine hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN3745661f-5d24-487d-e063-6294a90a5a683
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD3745661f-5d24-487d-e063-6294a90a5a683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2158-36729621580330 CAPSULE in 1 BOTTLE (67296-2158-3) 30 capsule2022-08-23NoNoCurrent