FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
50090-7340
11-digit product format
500907340
Labeler code
50090
Product ID
50090-7340_08581450-1a63-4283-bb13-792c443113ff
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
50090-7340-0Dicyclomine Hydrochloride30 in 1 BOTTLECAPSULE303
50090-7340-2Dicyclomine Hydrochloride60 in 1 BOTTLECAPSULE603
50090-7340-8Dicyclomine Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7340-0EA - Each50090-7340624599cc-a08b-4a60-acd6-a751c2133ba112024-11-05
50090-7340-2EA - Each50090-7340ba5bb068-109c-4fc4-a905-bdd146395a3b12024-11-05
50090-7340-8EA - Each50090-7340d5560eb0-c471-43be-81be-b183ca40809512024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7340DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241025_59422db6-b22d-447a-9393-46347406b338.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN59422db6-b22d-447a-9393-46347406b3383
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD59422db6-b22d-447a-9393-46347406b3383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7340-05009073400030 CAPSULE in 1 BOTTLE (50090-7340-0) 30 capsule2024-10-16NoNoHistorical
50090-7340-25009073400260 CAPSULE in 1 BOTTLE (50090-7340-2) 60 capsule2024-10-16NoNoHistorical
50090-7340-85009073400890 CAPSULE in 1 BOTTLE (50090-7340-8) 90 capsule2024-10-16NoNoHistorical