Dicyclomine Hydrochloride

Product NDC
42708-160
11-digit product format
427080160
Labeler code
42708
Product ID
42708-160_459bd8c8-e637-3bce-e063-6294a90af1ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
QPharma, 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
42708-160-56Dicyclomine Hydrochloride56 in 1 BOTTLE, PLASTICCAPSULE563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-160DICYCLOMINE HYDROCHLORIDE CAPSULE [QPHARMA, INC.]2Current NDC, 1 package rows20241123_f5dd6ecc-440d-6c47-e053-2a95a90a92d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNf5dd6ecc-440d-6c47-e053-2a95a90a92d33
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDf5dd6ecc-440d-6c47-e053-2a95a90a92d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42708-160-564270801605656 CAPSULE in 1 BOTTLE, PLASTIC (42708-160-56) 56 capsule2023-03-01YesNoHistorical