Dicyclomine Hydrochloride

Product NDC
66267-291
11-digit product format
662670291
Labeler code
66267
Product ID
66267-291_1fa6bbe7-2b07-02f5-e063-6394a90a10ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA085082
Marketing category
ANDA
Marketing start
1986-06-19
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-291-30Dicyclomine Hydrochloride30 in 1 BOTTLECAPSULE305
66267-291-60Dicyclomine Hydrochloride60 in 1 BOTTLECAPSULE605
66267-291-90Dicyclomine Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-291-30EA - Each66267-29148d46f3d-2b78-403f-8b37-147b8d16379d12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-291DICYCLOMINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240815_40e21575-320f-2ac6-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN40e21575-320f-2ac6-e054-00144ff88e885
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD40e21575-320f-2ac6-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-291-306626702913030 CAPSULE in 1 BOTTLE (66267-291-30) 30 capsule2016-11-090000-00-00NoNoCurrent
66267-291-606626702916060 CAPSULE in 1 BOTTLE (66267-291-60) 60 capsule2016-11-090000-00-00NoNoCurrent
66267-291-906626702919090 CAPSULE in 1 BOTTLE (66267-291-90) 90 capsule2016-11-090000-00-00NoNoCurrent