Ketorolac Tromethamine
- Product NDC
- 0404-9998
- 11-digit product format
- 004049998
- Labeler code
- 0404
- Product ID
- 0404-9998_b4499d86-8e17-4548-b970-a8d0a7ff763e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2024-04-05
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860092 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9998-01 | Ketorolac Tromethamine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 2 |
| 0404-9998-01 | Ketorolac Tromethamine | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9998 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 1 | Current NDC, 2 package rows | 20240522_1e65d11b-5aa9-4a6b-b5d6-c19828748fea.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 |
|---|
| 0404-9998-01 | 00404999801 | 1 VIAL in 1 BAG (0404-9998-01) / 1 mL in 1 VIAL | 1 vial | 2024-04-05 | No | No | Historical |