FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
72789-466
11-digit product format
727890466
Labeler code
72789
Product ID
72789-466_47ba6123-eefb-87a2-e063-6394a90a5f13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA216736
Marketing category
ANDA
Marketing start
2022-12-14
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
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 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
72789-466-01Dicyclomine hydrochloride100 in 1 BOTTLE, PLASTICTABLET1006
72789-466-30Dicyclomine hydrochloride30 in 1 BOTTLE, PLASTICTABLET306
72789-466-82Dicyclomine hydrochloride500 in 1 BOTTLE, PLASTICTABLET5006
72789-466-90Dicyclomine hydrochloride90 in 1 BOTTLE, PLASTICTABLET906
72789-466-95Dicyclomine hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-466-01EA - Each72789-466ec8f18e5-cc92-4aad-abe5-04cfb75a5d2112025-02-10
72789-466-30EA - Each72789-46612047325-139b-447a-a2a1-1e9aed5c118112025-09-12
72789-466-82EA - Each72789-466603bd2e7-0ecb-4ce1-adb5-d02e7be618c612025-02-10
72789-466-90EA - Each72789-4663c757ba1-95ee-4162-b5a9-e3617487c18412025-10-14
72789-466-95EA - Each72789-466a4867f67-3fea-4568-ae86-f735a718f2cd12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-466DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 5 package rows20250101_c0a6db32-1061-4721-b5ea-0082ff41acbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNc0a6db32-1061-4721-b5ea-0082ff41acbf6
991086dicyclomine hydrochloride 20 MG Oral TabletSCDc0a6db32-1061-4721-b5ea-0082ff41acbf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-466-0172789046601100 TABLET in 1 BOTTLE, PLASTIC (72789-466-01) 100 tablet2024-12-27NoNoHistorical
72789-466-307278904663030 TABLET in 1 BOTTLE, PLASTIC (72789-466-30) 30 tablet2025-07-28NoNoHistorical
72789-466-8272789046682500 TABLET in 1 BOTTLE, PLASTIC (72789-466-82) 500 tablet2024-12-27NoNoHistorical
72789-466-907278904669090 TABLET in 1 BOTTLE, PLASTIC (72789-466-90) 90 tablet2025-09-03NoNoHistorical
72789-466-95727890466951000 TABLET in 1 BOTTLE, PLASTIC (72789-466-95) 1000 tablet2024-12-27NoNoHistorical