Ketorolac Tromethamine
- Product NDC
- 0487-6232
- 11-digit product format
- 004876232
- Labeler code
- 0487
- Product ID
- 0487-6232_47e5aabd-6afa-7c55-e063-6394a90a2e81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Nephron Pharmaceuticals Corporation
- Application
- ANDA211445
- Marketing category
- ANDA
- Marketing start
- 2020-09-08
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 30 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
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 | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 1665459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0487-6232-01 | Ketorolac Tromethamine | 2 mL in 1 VIAL | INJECTION | 2 | | 4 |
| 0487-6232-01 | Ketorolac Tromethamine | 30 in 1 CARTON | INJECTION | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0487-6232 | KETOROLAC TROMETHAMINE INJECTION [NEPHRON SC INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241220_ae6c60c0-e88a-45b2-e053-2995a90ac62f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0487-6232-01 | 00487623201 | 30 VIAL in 1 CARTON (0487-6232-01) / 2 mL in 1 VIAL | 30 vial | 2020-09-08 | 0000-00-00 | No | No | Current |