FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
0517-1980
11-digit product format
005171980
Labeler code
0517
Product ID
0517-1980_9ffbe6bb-e13f-48d4-a8e0-55936b5167dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
American Regent, Inc.
Application
ANDA208353
Marketing category
ANDA
Marketing start
2017-09-01
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/2mL
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 HYDROCHLORIDE20 mg/2mL

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
0517-1980-01Dicyclomine hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION210
0517-1980-05Dicyclomine hydrochloride5 in 1 CARTONINJECTION, SOLUTION510
0517-1980-10Dicyclomine hydrochloride10 in 1 CARTONINJECTION, SOLUTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-1980DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]10Current NDC, Legacy NDC, 3 package rows20240130_cab4ecaf-8895-4ae8-add3-233d9cc570a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991065dicyclomine HCl 20 MG in 2 ML InjectionPSNcab4ecaf-8895-4ae8-add3-233d9cc570a810
9910652 ML dicyclomine hydrochloride 10 MG/ML InjectionSCDcab4ecaf-8895-4ae8-add3-233d9cc570a810
991065dicyclomine hydrochloride 20 MG per 2 ML InjectionSYcab4ecaf-8895-4ae8-add3-233d9cc570a810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-1980-01005171980012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0517-1980-05005171980055 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) 2017-09-110000-00-00NoNoCurrent
0517-1980-100051719801010 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) 2017-09-110000-00-00NoNoCurrent