Dicyclomine Hydrochloride

Product NDC
67296-1050
11-digit product format
672961050
Labeler code
67296
Product ID
67296-1050_d60f91b5-2531-145d-e053-2995a90af686
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA084285
Marketing category
ANDA
Marketing start
1974-09-30
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1050-3Dicyclomine Hydrochloride30 in 1 BOTTLECAPSULE304
67296-1050-4Dicyclomine Hydrochloride40 in 1 BOTTLECAPSULE404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1050DICYCLOMINE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]4Legacy NDC, 2 package rows20240712_4e3f0f1d-68c9-5313-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN4e3f0f1d-68c9-5313-e054-00144ff8d46c4
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD4e3f0f1d-68c9-5313-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1050-36729610500330 CAPSULE in 1 BOTTLE (67296-1050-3) 30 capsule1974-09-300000-00-00NoNoCurrent
67296-1050-46729610500440 CAPSULE in 1 BOTTLE (67296-1050-4) 40 capsule1974-09-300000-00-00NoNoCurrent