Dicyclomine Hydrochloride

Product NDC
68788-7948
11-digit product format
687887948
Labeler code
68788
Product ID
68788-7948_d26da867-6785-43f5-9358-392296e52627
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040319
Marketing category
ANDA
Marketing start
2021-07-08
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7948-2EA - Each68788-79488c998228-2c71-4ce6-b319-08ecb88ab7fb12021-08-05
68788-7948-3EA - Each68788-79487dfe3459-0c4f-47c0-a783-9a123107db9e12021-08-05
68788-7948-6EA - Each68788-7948a773776f-0a3c-4292-9ab0-ac36d832c09812021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7948-168788794801100 CAPSULE in 1 BOTTLE, PLASTIC (68788-7948-1) 100 capsule2021-07-080000-00-00NoNoCurrent
68788-7948-26878879480220 CAPSULE in 1 BOTTLE, PLASTIC (68788-7948-2) 20 capsule2021-07-080000-00-00NoNoCurrent
68788-7948-36878879480330 CAPSULE in 1 BOTTLE, PLASTIC (68788-7948-3) 30 capsule2021-07-080000-00-00NoNoCurrent
68788-7948-66878879480660 CAPSULE in 1 BOTTLE, PLASTIC (68788-7948-6) 60 capsule2021-07-080000-00-00NoNoCurrent