Dicyclomine hydrochloride

Product NDC
50090-7729
11-digit product format
500907729
Labeler code
50090
Product ID
50090-7729_bbb7953e-d828-4c3c-b9e0-b4d82f816bb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA218018
Marketing category
ANDA
Marketing start
2024-07-01
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
50090-7729-0Dicyclomine hydrochloride30 in 1 BOTTLECAPSULE301
50090-7729-2Dicyclomine hydrochloride60 in 1 BOTTLECAPSULE601
50090-7729-8Dicyclomine hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7729-0EA - Each50090-772921ef7116-ddb7-4106-82fa-3e6ee6d173a412025-12-16
50090-7729-2EA - Each50090-772989150532-19b5-48ba-b872-9ed6ab8a9cc212025-12-16
50090-7729-8EA - Each50090-772951d611f9-d76d-4ee7-9e23-a588d6c5856312025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNacb5ab87-2eb4-4fc9-b7f1-cc8cb71bd73b1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDacb5ab87-2eb4-4fc9-b7f1-cc8cb71bd73b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7729-05009077290030 CAPSULE in 1 BOTTLE (50090-7729-0) 30 capsule2025-10-27NoNoCurrent
50090-7729-25009077290260 CAPSULE in 1 BOTTLE (50090-7729-2) 60 capsule2025-10-27NoNoCurrent
50090-7729-85009077290890 CAPSULE in 1 BOTTLE (50090-7729-8) 90 capsule2025-10-27NoNoCurrent