FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
69452-311
11-digit product format
694520311
Labeler code
69452
Product ID
69452-311_1927b1f0-6fee-f127-e063-6394a90a05a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217916
Marketing category
ANDA
Marketing start
2023-09-13
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
69452-311-20Dicyclomine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1002
69452-311-32Dicyclomine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-311-32EA - Each69452-311f4f5bd36-054a-4570-ac73-3cd84836bc0d12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-311DICYCLOMINE HYDROCHLORIDE TABLET [BIONPHARMA INC.]2Current NDC, 2 package rows20240525_051bfee3-06cf-309a-e063-6394a90a0bb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN3ee013cc-ab23-40a1-a44d-1d027c63b1324
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3ee013cc-ab23-40a1-a44d-1d027c63b1324
991086dicyclomine HCl 20 MG Oral TabletPSN051bfee3-06cf-309a-e063-6394a90a0bb32
991086dicyclomine HCl 20 MG Oral TabletPSN8561b68a-c88b-4047-9fcf-2df7344543b22
991086dicyclomine hydrochloride 20 MG Oral TabletSCD051bfee3-06cf-309a-e063-6394a90a0bb32
991086dicyclomine hydrochloride 20 MG Oral TabletSCD8561b68a-c88b-4047-9fcf-2df7344543b22
991086dicyclomine HCl 20 MG Oral TabletPSN2b33ef28-2b71-46c4-bb2f-694fefcd59ab1
991086dicyclomine HCl 20 MG Oral TabletPSN4dddbff3-2531-b35e-e063-6294a90a1d3b1
991086dicyclomine HCl 20 MG Oral TabletPSN5198641d-bba1-b053-e063-6394a90a592b1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD2b33ef28-2b71-46c4-bb2f-694fefcd59ab1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD4dddbff3-2531-b35e-e063-6294a90a1d3b1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD5198641d-bba1-b053-e063-6394a90a592b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-311-2069452031120100 TABLET in 1 BOTTLE, PLASTIC (69452-311-20) 100 tablet2023-09-13NoNoCurrent
69452-311-32694520311321000 TABLET in 1 BOTTLE, PLASTIC (69452-311-32) 1000 tablet2024-05-23NoNoCurrent