Ketorolac Tromethamine
- Product NDC
- 52584-584
- 11-digit product format
- 525840584
- Labeler code
- 52584
- Product ID
- 52584-584_f5122a2b-097c-4073-b6cb-45b6292d9544
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2018-05-23
- Marketing end
- 2021-08-31
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 30 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-584-93 | 52584058493 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-584-93) > 1 mL in 1 VIAL, SINGLE-DOSE | 2018-05-23 | 2021-08-31 | No | No | Current |