Ketorolac Tromethamine
- Product NDC
- 70512-844
- 11-digit product format
- 705120844
- Labeler code
- 70512
- Product ID
- 70512-844_457271ef-6508-6596-e063-6394a90a039d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- SOLA Pharmaceuticals, LLC
- Application
- ANDA217789
- Marketing category
- ANDA
- Marketing start
- 2024-10-22
- 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
- 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 | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860092, 1665459, 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70512-844-01 | Ketorolac Tromethamine | 2 mL in 1 VIAL | INJECTION | 2 | | 9 |
| 70512-844-25 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION | 25 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70512-844 | KETOROLAC TROMETHAMINE INJECTION [SOLA PHARMACEUTICALS, LLC] | 8 | Current NDC, 2 package rows | 20241025_2301a6a2-b88a-4c0d-bb6c-ad4a8af7da39.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 |
|---|
| 70512-844-01 | 70512084401 | 2 mL in 1 VIAL | 2 ml | | | | Historical |
| 70512-844-25 | 70512084425 | 25 VIAL in 1 CARTON (70512-844-25) / 2 mL in 1 VIAL (70512-844-01) | 25 vial | 2024-10-22 | No | No | Historical |