Dicyclomine Hydrochloride

Product NDC
50090-7341
11-digit product format
500907341
Labeler code
50090
Product ID
50090-7341_bf77cecb-89c8-465c-9907-37edd9e6ec33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA217054
Marketing category
ANDA
Marketing start
2023-02-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7341-1Dicyclomine Hydrochloride28 in 1 BOTTLECAPSULE283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7341-1EA - Each50090-7341f417b0f4-4281-41cf-9834-6e580a22d8f712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7341DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241025_4f6f4402-865b-44fb-9bfe-4e224d57e6dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN4f6f4402-865b-44fb-9bfe-4e224d57e6dc3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD4f6f4402-865b-44fb-9bfe-4e224d57e6dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7341-15009073410128 CAPSULE in 1 BOTTLE (50090-7341-1) 28 capsule2024-10-16NoNoHistorical