Dicyclomine Hydrochloride

Product NDC
0378-1620
11-digit product format
003781620
Labeler code
0378
Product ID
0378-1620_9923776f-ab42-4f59-971e-542147dd6b7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dicyclomine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA040317
Marketing category
ANDA
Marketing start
1999-11-03
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1620-01EA - Each0378-1620cfcf4714-4785-4dc6-bd48-94a3f275c24f12012-07-24
0378-1620-05EA - Each0378-16209b1514de-a954-4f8f-8428-ee2ec7e995b912012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNdac1bf89-575b-442e-99ff-6f94da4d872e15
991086dicyclomine HCl 20 MG Oral TabletPSNdac1bf89-575b-442e-99ff-6f94da4d872e15
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDdac1bf89-575b-442e-99ff-6f94da4d872e15
991086dicyclomine hydrochloride 20 MG Oral TabletSCDdac1bf89-575b-442e-99ff-6f94da4d872e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1620-0100378162001100 TABLET in 1 BOTTLE, PLASTIC (0378-1620-01) 100 tablet1999-11-030000-00-00NoNoCurrent
0378-1620-0500378162005500 TABLET in 1 BOTTLE, PLASTIC (0378-1620-05) 500 tablet1999-11-030000-00-00NoNoCurrent