FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
63323-842
11-digit product format
633230842
Labeler code
63323
Product ID
63323-842_19096abe-de13-44f4-9028-f918519e34f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Fresenius Kabi USA, LLC
Application
ANDA210257
Marketing category
ANDA
Marketing start
2019-09-12
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991065

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
63323-842-02Dicyclomine Hydrochloride5 in 1 CARTONINJECTION, SOLUTION53
63323-842-21Dicyclomine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-842-02ML - Milliliter63323-842470bccfa-b9e4-4810-bc83-5b98c92daa8712019-11-12
63323-842-21ML - Milliliter63323-842123e9fd2-a31e-45b2-8a58-8f3eda318c5412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-842DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20240727_350ce812-b9a7-401a-9793-55d2e14bb760.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991065dicyclomine HCl 20 MG in 2 ML InjectionPSN350ce812-b9a7-401a-9793-55d2e14bb7603
9910652 ML dicyclomine hydrochloride 10 MG/ML InjectionSCD350ce812-b9a7-401a-9793-55d2e14bb7603
991065dicyclomine hydrochloride 20 MG per 2 ML InjectionSY350ce812-b9a7-401a-9793-55d2e14bb7603
991065dicyclomine HCl 20 MG in 2 ML InjectionPSNc77ef2f7-a846-5e05-e053-2995a90aaae02
9910652 ML dicyclomine hydrochloride 10 MG/ML InjectionSCDc77ef2f7-a846-5e05-e053-2995a90aaae02
991065dicyclomine hydrochloride 20 MG per 2 ML InjectionSYc77ef2f7-a846-5e05-e053-2995a90aaae02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-842-02633230842025 VIAL, SINGLE-DOSE in 1 CARTON (63323-842-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-842-21) 2019-09-120000-00-00NoNoCurrent
63323-842-21633230842212 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical