KETROLAC TROMETHAMINE
- Product NDC
- 83854-021
- 11-digit product format
- 838540021
- Labeler code
- 83854
- Product ID
- 83854-021_5c9999ae-45e2-b2e5-e063-6294a90a87f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Anthea Pharma Private Limited
- Application
- ANDA221041
- Marketing category
- ANDA
- Marketing start
- 2026-09-25
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 15 mg/mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KETROLAC TROMETHAMINE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 15 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83854-021-10 | 83854002110 | 10 VIAL in 1 CARTON (83854-021-10) / 1 mL in 1 VIAL (83854-021-01) | 10 vial | 2026-09-25 | No | No | Current |
| 83854-021-25 | 83854002125 | 25 VIAL in 1 CARTON (83854-021-25) / 1 mL in 1 VIAL (83854-021-01) | 25 vial | 2026-09-25 | No | No | Current |