FDA.reportPublic FDA data

DICYCLOMINE HYDROCHLORIDE

Product NDC
72789-522
11-digit product format
727890522
Labeler code
72789
Product ID
72789-522_51043fad-02f3-b7fc-e063-6394a90a31f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA216639
Marketing category
ANDA
Marketing start
2025-09-30
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991061

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-522-01DICYCLOMINE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICCAPSULE1005
72789-522-20DICYCLOMINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICCAPSULE205
72789-522-28DICYCLOMINE HYDROCHLORIDE28 in 1 BOTTLE, PLASTICCAPSULE285
72789-522-30DICYCLOMINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE305
72789-522-90DICYCLOMINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICCAPSULE905
72789-522-93DICYCLOMINE HYDROCHLORIDE180 in 1 BOTTLE, PLASTICCAPSULE1805
72789-522-95DICYCLOMINE HYDROCHLORIDE1000 in 1 BOTTLE, PLASTICCAPSULE10005
72789-522-98DICYCLOMINE HYDROCHLORIDE120 in 1 BOTTLE, PLASTICCAPSULE1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-522-01EA - Each72789-5225f6aff55-47e5-432c-8728-4ba37100311712025-11-13
72789-522-28EA - Each72789-522fa53e4ae-6295-4d35-bf56-2402122d490212026-02-05
72789-522-30EA - Each72789-522126e09c8-7c3d-46ec-a517-6b5402316b6312026-03-17
72789-522-90EA - Each72789-522cba78682-032b-44f2-9a30-16bdc1f0143e12025-11-13
72789-522-93EA - Each72789-52297cc5bca-96c3-475d-bf9b-a2e14bc1193412025-11-13
72789-522-95EA - Each72789-52275680593-aeab-4d07-b1f9-e1c189e4e98912025-11-13
72789-522-98EA - Each72789-5220e53bf75-a0f3-4851-aa77-28cbc224a86912025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN400ac94f-2cf6-bd52-e063-6294a90a4f055
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD400ac94f-2cf6-bd52-e063-6294a90a4f055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-522-0172789052201100 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-01) 100 capsule2025-09-30NoNoCurrent
72789-522-207278905222020 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-20) 20 capsule2026-05-04NoNoCurrent
72789-522-287278905222828 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-28) 28 capsule2026-01-07NoNoCurrent
72789-522-307278905223030 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-30) 30 capsule2026-02-19NoNoCurrent
72789-522-907278905229090 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-90) 90 capsule2025-09-30NoNoCurrent
72789-522-9372789052293180 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-93) 180 capsule2025-09-30NoNoCurrent
72789-522-95727890522951000 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-95) 1000 capsule2025-09-30NoNoCurrent
72789-522-9872789052298120 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-98) 120 capsule2025-09-30NoNoCurrent