FDA.reportPublic FDA data

DICYCLOMINE HYDROCHLORIDE

Product NDC
72266-127
11-digit product format
722660127
Labeler code
72266
Product ID
72266-127_3f2b31a2-9bf4-0d55-e063-6394a90ae598
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Fosun Pharma USA Inc.
Application
ANDA210979
Marketing category
ANDA
Marketing start
2019-12-30
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/mL
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/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
72266-127-01DICYCLOMINE HYDROCHLORIDE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION25
72266-127-05DICYCLOMINE HYDROCHLORIDE5 in 1 CARTONINJECTION, SOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-127-01ML - Milliliter72266-127489117cf-6a67-4704-985b-ca799771e02f12020-02-13
72266-127-05ML - Milliliter72266-1278428c63a-c983-45da-b16c-35b971c15a0112020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-127DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [FOSUN PHARMA USA INC.]4Current NDC, Legacy NDC, 2 package rows20240509_cbc22f25-e100-4c59-8f38-5f82113166fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991065dicyclomine HCl 20 MG in 2 ML InjectionPSNcbc22f25-e100-4c59-8f38-5f82113166fb5
9910652 ML dicyclomine hydrochloride 10 MG/ML InjectionSCDcbc22f25-e100-4c59-8f38-5f82113166fb5
991065dicyclomine hydrochloride 20 MG per 2 ML InjectionSYcbc22f25-e100-4c59-8f38-5f82113166fb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-127-01722660127012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
72266-127-05722660127055 VIAL, SINGLE-DOSE in 1 CARTON (72266-127-05) / 2 mL in 1 VIAL, SINGLE-DOSE (72266-127-01) 2019-12-300000-00-00NoNoCurrent