Dicyclomine Hydrochloride

Product NDC
31722-963
11-digit product format
317220963
Labeler code
31722
Product ID
31722-963_f7930599-56ae-4e8f-a9bd-368f63b55ed1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212058
Marketing category
ANDA
Marketing start
2019-11-08
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/2mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-963-31Dicyclomine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION22
31722-963-32Dicyclomine Hydrochloride5 in 1 BOXINJECTION, SOLUTION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-963-31ML - Milliliter31722-9631cbdc10e-d8fc-457e-b058-acea0ad84f8212020-08-06
31722-963-32ML - Milliliter31722-963d4ddc9cf-28a5-4073-a9e9-9c7e559cc1f712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-963DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.]2Legacy NDC, 2 package rows20210220_e2c26eb8-5a62-43b7-8791-3d0099a9e0e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991065dicyclomine HCl 20 MG in 2 ML InjectionPSNe2c26eb8-5a62-43b7-8791-3d0099a9e0e32
9910652 ML dicyclomine hydrochloride 10 MG/ML InjectionSCDe2c26eb8-5a62-43b7-8791-3d0099a9e0e32
991065dicyclomine hydrochloride 20 MG per 2 ML InjectionSYe2c26eb8-5a62-43b7-8791-3d0099a9e0e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-963-31317220963312 mL in 1 VIAL2 mlHistorical
31722-963-32317220963325 VIAL in 1 BOX (31722-963-32) > 2 mL in 1 VIAL (31722-963-31) 5 vial2019-11-080000-00-00NoNoCurrent