Timolol Maleate

Product NDC
50383-021
11-digit product format
503830021
Labeler code
50383
Product ID
50383-021_66806aed-f023-4e82-98b5-fd361bf15afe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA075163
Marketing category
ANDA
Marketing start
2002-09-10
Marketing end
0000-00-00
Substance
TIMOLOL MALEATE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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
50383-021-05ML - Milliliter50383-02146305671-33ce-45e7-a003-b7330372adaf12012-07-24
50383-021-10ML - Milliliter50383-021f231c7a3-1392-46c1-be49-fe52f2df2e8f12012-07-24
50383-021-15ML - Milliliter50383-02143470d9f-6d79-4719-b0f7-703472eeb1d112012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-021-05503830021051 BOTTLE in 1 CARTON (50383-021-05) > 5 mL in 1 BOTTLE1 bottle2002-09-100000-00-00NoNoCurrent
50383-021-10503830021101 BOTTLE in 1 CARTON (50383-021-10) > 10 mL in 1 BOTTLE1 bottle2002-09-100000-00-00NoNoCurrent
50383-021-15503830021151 BOTTLE in 1 CARTON (50383-021-15) > 15 mL in 1 BOTTLE1 bottle2002-09-100000-00-00NoNoCurrent