Dicyclomine Hydrochloride

Product NDC
70518-4432
11-digit product format
705184432
Labeler code
70518
Product ID
70518-4432_3c2eea67-bae1-297c-e063-6394a90a13f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217054
Marketing category
ANDA
Marketing start
2025-08-12
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
CQ903KQA31DICYCLOMINE HYDROCHLORIDE67-92-5DICYCLOMINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4432-07051844320030 CAPSULE in 1 BLISTER PACK (70518-4432-0) 30 capsule2025-08-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine HydrochlorideREMEDYREPACK INC.2025-08-12HUMAN PRESCRIPTION DRUG LABEL1