FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
31722-079
11-digit product format
317220079
Labeler code
31722
Product ID
31722-079_24d1b166-e43d-91de-e063-6394a90ae579
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217566
Marketing category
ANDA
Marketing start
2024-05-07
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

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
31722-079-01Dicyclomine hydrochloride100 in 1 BOTTLETABLET1001
31722-079-10Dicyclomine hydrochloride1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-079-01EA - Each31722-079401be1a9-b14f-424f-868c-68f45614d0d912025-01-14
31722-079-10EA - Each31722-0799675785c-e2ad-4264-b0ab-6157f83ee23612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-079DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20241020_0590c805-537e-46d3-9500-f4942c1df2ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN3c6dec02-b146-dd36-e063-6294a90ad7d23
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3c6dec02-b146-dd36-e063-6294a90ad7d23
991086dicyclomine HCl 20 MG Oral TabletPSN0590c805-537e-46d3-9500-f4942c1df2ea1
991086dicyclomine HCl 20 MG Oral TabletPSN380270a8-d0a6-44cb-bb34-f91db6e6ac711
991086dicyclomine HCl 20 MG Oral TabletPSN43e30378-6376-caab-e063-6294a90a86961
991086dicyclomine hydrochloride 20 MG Oral TabletSCD0590c805-537e-46d3-9500-f4942c1df2ea1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD380270a8-d0a6-44cb-bb34-f91db6e6ac711
991086dicyclomine hydrochloride 20 MG Oral TabletSCD43e30378-6376-caab-e063-6294a90a86961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-079-0131722007901100 TABLET in 1 BOTTLE (31722-079-01) 100 tablet2024-05-07NoNoCurrent
31722-079-10317220079101000 TABLET in 1 BOTTLE (31722-079-10) 1000 tablet2024-05-07NoNoCurrent