Ketorolac Tromethamine

Product NDC
68083-103
11-digit product format
680830103
Labeler code
68083
Product ID
68083-103_b50a70ef-f6e8-482d-855d-ea87f0620f00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA076722
Marketing category
ANDA
Marketing start
2015-07-24
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-103-016808301030110 SYRINGE in 1 CARTON (68083-103-01) > 1 mL in 1 SYRINGE10 syringe2015-07-240000-00-00NoNoCurrent