Cyclopentolate Hydrochloride

Product NDC
17478-097
11-digit product format
174780097
Labeler code
17478
Product ID
17478-097_ea22dcc7-ab6d-432b-a668-ac87777d0845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclopentolate Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA040165
Marketing category
ANDA
Marketing start
1997-01-13
Marketing end
0000-00-00
Substance
CYCLOPENTOLATE HYDROCHLORIDE
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-097-02ML - Milliliter17478-0970ac89231-81a7-44bf-8fd7-96056bd5cff712012-07-24
17478-097-10ML - Milliliter17478-0971836e4cb-b433-4674-9add-a1d570e70cec12012-07-24
17478-097-12ML - Milliliter17478-09710258e88-c9d1-41be-a2d0-82019ef0179d12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-097-02174780097021 BOTTLE, DROPPER in 1 CARTON (17478-097-02) > 2 mL in 1 BOTTLE, DROPPER1997-01-130000-00-00NoNoCurrent
17478-097-10174780097101 BOTTLE, DROPPER in 1 CARTON (17478-097-10) > 5 mL in 1 BOTTLE, DROPPER1997-01-130000-00-00NoNoCurrent
17478-097-12174780097121 BOTTLE, DROPPER in 1 CARTON (17478-097-12) > 15 mL in 1 BOTTLE, DROPPER1997-01-130000-00-00NoNoCurrent