FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
51655-219
11-digit product format
516550219
Labeler code
51655
Product ID
51655-219_49a1363f-330d-fccd-e063-6394a90a81c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA085082
Marketing category
ANDA
Marketing start
2021-06-08
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-219-272026-01-29C16284748780-149896155-c6dc-586f-e063-e6dba90add90These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS . DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
51655-219-522026-01-29C16284748780-149896155-c6dc-586f-e063-e6dba90add90These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS . DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-219-27Dicyclomine Hydrochloride12 in 1 BOTTLE, PLASTICCAPSULE122
51655-219-52Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-219DICYCLOMINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS]1Current NDC, 2 package rows20230224_d9bb7ff1-8dbc-d191-e053-2995a90a13db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNd9bb7ff1-8dbc-d191-e053-2995a90a13db2
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDd9bb7ff1-8dbc-d191-e053-2995a90a13db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-219-275165502192712 CAPSULE in 1 BOTTLE, PLASTIC (51655-219-27) 12 capsule2022-01-20NoNoHistorical
51655-219-525165502195230 CAPSULE in 1 BOTTLE, PLASTIC (51655-219-52) 30 capsule2021-06-08NoNoHistorical