FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
72888-105
Requested package NDC
72888-105-05
11-digit product format
728880105
Labeler code
72888
Product ID
72888-105_57312da9-892d-e23f-e063-6294a90adc76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advagen Pharma Ltd.,
Application
ANDA216515
Marketing category
ANDA
Marketing start
2026-07-17
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC]; Cholinergic Antagonists [MoA]
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEAdvagen Pharma Ltd.,a66aa5c7-1fde-42fc-9e1f-7f4cc9adac9c2026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216515
application number: ANDA216515
ndc (package): 72888-105-05
ndc (product): 72888-105
ndc11 (package): 72888010505

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CQ903KQA31Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
991061Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a66aa5c7-1fde-42fc-9e1f-7f4cc9adac9cAvailable on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
72888-105-0572888010505500 CAPSULE in 1 BOTTLE (72888-105-05)500 capsule2026-07-170Current