Dicyclomine Hydrochloride

Product NDC
71205-428
11-digit product format
712050428
Labeler code
71205
Product ID
71205-428_254cd89b-86ad-4846-a5d3-5fe66e0d1e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA085082
Marketing category
ANDA
Marketing start
1986-06-19
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
71205-428-157120504281515 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-15) 15 capsule2020-03-12NoNoHistorical
71205-428-207120504282020 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-20) 20 capsule2020-03-12NoNoHistorical
71205-428-307120504283030 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-30) 30 capsule2020-03-12NoNoHistorical
71205-428-607120504286060 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-60) 60 capsule2020-03-12NoNoHistorical
71205-428-907120504289090 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-90) 90 capsule2020-03-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dicyclomine HydrochlorideProficient Rx LP2023-07-01HUMAN PRESCRIPTION DRUG LABEL2