FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
17856-2261
11-digit product format
178562261
Labeler code
17856
Product ID
17856-2261_362374f1-a8ef-120d-e063-6394a90a0d6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA214721
Marketing category
ANDA
Marketing start
2025-03-04
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/5mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991082

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-2261-1Dicyclomine Hydrochloride72 mL in 1 BOX, UNIT-DOSESOLUTION723
17856-2261-2Dicyclomine Hydrochloride72 mL in 1 BOX, UNIT-DOSESOLUTION723

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-2261-1ML - Milliliter17856-22613da65de5-af77-43d6-8935-6589fdaef6f812025-05-14
17856-2261-2ML - Milliliter17856-2261a0ab622e-03d5-46c1-957d-52a055fb3f5b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-2261DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]3Current NDC, 2 package rows20250529_2f89e438-6a8a-917e-e063-6294a90a1c23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991082dicyclomine HCl 10 MG in 5 mL Oral SolutionPSN2f89e438-6a8a-917e-e063-6294a90a1c233
991082dicyclomine hydrochloride 2 MG/ML Oral SolutionSCD2f89e438-6a8a-917e-e063-6294a90a1c233
991082dicyclomine HCl 10 MG per 5 ML Oral SolutionSY2f89e438-6a8a-917e-e063-6294a90a1c233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-2261-11785622610172 mL in 1 BOX, UNIT-DOSE (17856-2261-1) 72 ml2025-03-04NoNoHistorical
17856-2261-21785622610272 mL in 1 BOX, UNIT-DOSE (17856-2261-2) 72 ml2025-03-04NoNoHistorical