FDA.reportPublic FDA data

dicyclomine hydrochloride

Product NDC
0603-1161
11-digit product format
006031161
Labeler code
0603
Product ID
0603-1161_fc9f1cd7-9096-40ae-99d3-c001d69fe165
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dicyclomine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA040169
Marketing category
ANDA
Marketing start
2005-06-23
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991082

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
0603-1161-58dicyclomine hydrochloride473 mL in 1 BOTTLE, PLASTICSOLUTION4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-1161-58ML - Milliliter0603-11617fbcc101-d82d-4199-9244-8993e2233eea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SORBITOLINACTIVE INGREDIENT506T60A25RDICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
SORBITOLINACTIVE INGREDIENT506T60A25RDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SUCROSEINACTIVE INGREDIENTC151H8M554DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
SUCROSEINACTIVE INGREDIENTC151H8M554DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RDICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-1161DICYCLOMINE HYDROCHLORIDE SOLUTION [ENDO USA, INC.]7Current NDC, Legacy NDC, 1 package rows20250321_bb099db9-f635-4a64-8892-6236971dec45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991082dicyclomine HCl 10 MG in 5 mL Oral SolutionPSNbb099db9-f635-4a64-8892-6236971dec458
991082dicyclomine hydrochloride 2 MG/ML Oral SolutionSCDbb099db9-f635-4a64-8892-6236971dec458
991082dicyclomine HCl 10 MG per 5 ML Oral SolutionSYbb099db9-f635-4a64-8892-6236971dec458
991082dicyclomine HCl 10 MG in 5 mL Oral SolutionPSN95a0f538-4c94-487a-b85f-424eddd594593
991082dicyclomine hydrochloride 2 MG/ML Oral SolutionSCD95a0f538-4c94-487a-b85f-424eddd594593
991082dicyclomine HCl 10 MG per 5 ML Oral SolutionSY95a0f538-4c94-487a-b85f-424eddd594593
991082dicyclomine HCl 10 MG in 5 mL Oral SolutionPSNda753e89-d5ec-4183-920b-aa1c4e8c21972
991082dicyclomine hydrochloride 2 MG/ML Oral SolutionSCDda753e89-d5ec-4183-920b-aa1c4e8c21972
991082dicyclomine HCl 10 MG per 5 ML Oral SolutionSYda753e89-d5ec-4183-920b-aa1c4e8c21972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-1161-5800603116158473 mL in 1 BOTTLE, PLASTIC (0603-1161-58) 473 ml2005-06-230000-00-00NoNoCurrent