Dicyclomine

Product NDC
0615-0327
11-digit product format
006150327
Labeler code
0615
Product ID
0615-0327_abfbd596-892a-4784-9681-8624fe56431b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA040204
Marketing category
ANDA
Marketing start
1997-02-28
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-0327-392021-04-16C16284748780-197449f38-cfce-f6ea-e053-dbdaa90aa703b8c72fd8-6030-4c0a-80a6-d36cf698a576
0615-0327-392019-11-13C16284748780-197449f38-cfce-f6ea-e053-dbdaa90aa703b8c72fd8-6030-4c0a-80a6-d36cf698a576

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-0327-390061503273930 CAPSULE in 1 BLISTER PACK (0615-0327-39) 30 capsule2010-01-150000-00-00NoNoCurrent