Ketorolac Tromethamine

Product NDC
47781-583
11-digit product format
477810583
Labeler code
47781
Product ID
47781-583_baae0258-98e2-90c9-f0b7-610b1ee55139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA204216
Marketing category
ANDA
Marketing start
2017-09-29
Marketing end
2021-11-01
Substance
KETOROLAC TROMETHAMINE
Active strength
15 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-583-68ML - Milliliter47781-58392908ea7-61ee-4782-97a5-4f5f22946e1012017-11-06
47781-583-93ML - Milliliter47781-58370aa7f63-f50f-4825-85ad-f6cf94ecff9a12017-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-583-684778105836825 VIAL, SINGLE-DOSE in 1 CARTON (47781-583-68) > 1 mL in 1 VIAL, SINGLE-DOSE (47781-583-93) 2017-09-292021-11-01NoNoCurrent