Dicyclomine Hydrochloride

Product NDC
51407-821
11-digit product format
514070821
Labeler code
51407
Product ID
51407-821_4ffd6b23-7f66-0199-e063-6394a90a863f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA216782
Marketing category
ANDA
Marketing start
2023-06-01
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
51407-821-12Dicyclomine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-821-12EA - Each51407-8211ba94b9e-e018-4190-bd51-71f3726e517f12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-821DICYCLOMINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 1 package rows20240110_05552560-6986-f9e8-e063-6394a90a4af0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN05552560-6986-f9e8-e063-6394a90a4af04
991086dicyclomine hydrochloride 20 MG Oral TabletSCD05552560-6986-f9e8-e063-6394a90a4af04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-821-1251407082112120 TABLET in 1 BOTTLE, PLASTIC (51407-821-12) 120 tablet2023-07-19NoNoHistorical