FDA.reportPublic FDA data

DICYCLOMINE HYDROCHLORIDE

Product NDC
52959-168
11-digit product format
529590168
Labeler code
52959
Product ID
52959-168_5fb0acc3-3e30-732e-e053-2a91aa0af3cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company inc.
Application
ANDA040319
Marketing category
ANDA
Marketing start
2017-01-03
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-168-002020-01-31C16284748780-19d75b9cf-eb82-f424-e053-dadaa90a57ce5fb0acc3-3e2f-732e-e053-2a91aa0af3cc
52959-168-122020-01-31C16284748780-19d75b9cf-eb82-f424-e053-dadaa90a57ce5fb0acc3-3e2f-732e-e053-2a91aa0af3cc
52959-168-302020-01-31C16284748780-19d75b9cf-eb82-f424-e053-dadaa90a57ce5fb0acc3-3e2f-732e-e053-2a91aa0af3cc
52959-168-402020-01-31C16284748780-19d75b9cf-eb82-f424-e053-dadaa90a57ce5fb0acc3-3e2f-732e-e053-2a91aa0af3cc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-168-00DICYCLOMINE HYDROCHLORIDE100 in 1 CONTAINERCAPSULE1001
52959-168-12DICYCLOMINE HYDROCHLORIDE12 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKCAPSULE121
52959-168-30DICYCLOMINE HYDROCHLORIDE30 in 1 CONTAINERCAPSULE301
52959-168-40DICYCLOMINE HYDROCHLORIDE40 in 1 CONTAINERCAPSULE401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-168DICYCLOMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY INC.]1Legacy NDC, 4 package rows20171207_5fb0acc3-3e2f-732e-e053-2a91aa0af3cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN5fb0acc3-3e2f-732e-e053-2a91aa0af3cc1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD5fb0acc3-3e2f-732e-e053-2a91aa0af3cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-168-0052959016800100 in 1 CONTAINERHistorical
52959-168-125295901681212 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKHistorical
52959-168-305295901683030 in 1 CONTAINERHistorical
52959-168-405295901684040 in 1 CONTAINERHistorical