Dicyclomine Hydrochloride

Product NDC
63629-8049
11-digit product format
636298049
Labeler code
63629
Product ID
63629-8049_a4a39291-f464-4036-89d2-7d4dfcfd963f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8049-1Dicyclomine Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8049DICYCLOMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]2Legacy NDC, 1 package rows20220119_a4a39291-f464-4036-89d2-7d4dfcfd963f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNa4a39291-f464-4036-89d2-7d4dfcfd963f2
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDa4a39291-f464-4036-89d2-7d4dfcfd963f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8049-16362980490130 CAPSULE in 1 BOTTLE (63629-8049-1) 30 capsule2019-07-180000-00-00NoNoCurrent