FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
24201-585
11-digit product format
242010585
Labeler code
24201
Product ID
24201-585_9978f15f-dec2-613a-e053-2a95a90a8166
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride Injection
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Leucadia Pharmaceuticals
Application
ANDA210788
Marketing category
ANDA
Marketing start
2019-10-07
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/2mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24201-585DDiscontinued by firm2026-07-31
excluded packagepackage24201-58524201-585-10DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210788-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE10MG/MLINJECTABLE / INJECTION2019-02-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210788-001DICYCLOMINE HYDROCHLORIDE10MG/MLINJECTABLE / INJECTION2019-02-11a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24201-585-10ML - Milliliter24201-5856874f0b3-c20b-4bfc-91b7-22c94f18f18b12019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24201-585-102420105851010 VIAL in 1 BOX (24201-585-10) > 2 mL in 1 VIAL10 vial2019-10-070000-00-00NoNoCurrent