FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
51655-548
11-digit product format
516550548
Labeler code
51655
Product ID
51655-548_4b48c19f-97bb-f578-e063-6394a90af41f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA216736
Marketing category
ANDA
Marketing start
2023-06-12
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-548-262026-01-29C16284748780-149896155-b7f1-586f-e063-e6dba90add90These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
51655-548-522026-01-29C16284748780-149896155-b7f1-586f-e063-e6dba90add90These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-548-26Dicyclomine hydrochloride90 in 1 BOTTLE, PLASTICTABLET904
51655-548-52Dicyclomine hydrochloride30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-548DICYCLOMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240720_1d9acff5-6e8c-58dd-e063-6394a90a38f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN1d9acff5-6e8c-58dd-e063-6394a90a38f24
991086dicyclomine hydrochloride 20 MG Oral TabletSCD1d9acff5-6e8c-58dd-e063-6394a90a38f24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-548-265165505482690 TABLET in 1 BOTTLE, PLASTIC (51655-548-26) 90 tablet2023-07-14NoNoCurrent
51655-548-525165505485230 TABLET in 1 BOTTLE, PLASTIC (51655-548-52) 30 tablet2023-06-12NoNoCurrent