ketorolac tromethamine
- Product NDC
- 72266-234
- 11-digit product format
- 722660234
- Labeler code
- 72266
- Product ID
- 72266-234_228ec94a-f777-f61b-e063-6394a90a21a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- FOSUN PHARMA USA INC
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2023-06-23
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ketorolac tromethamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72266-234-01 | ketorolac tromethamine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 16 |
| 72266-234-25 | ketorolac tromethamine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72266-234 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FOSUN PHARMA USA INC] | 16 | Current NDC, 2 package rows | 20250306_1aae6a4d-0909-4672-aa26-e3f2d8c4d413.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72266-234-01 | 72266023401 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 72266-234-25 | 72266023425 | 25 VIAL in 1 CARTON (72266-234-25) / 1 mL in 1 VIAL (72266-234-01) | 25 vial | 2023-06-23 | No | No | Current |