KETOROLAC TROMETHAMINE
- Product NDC
- 69315-260
- 11-digit product format
- 693150260
- Labeler code
- 69315
- Product ID
- 69315-260_aedd35df-9c0a-4dfb-ac09-dcb63675a420
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA215745
- Marketing category
- ANDA
- Marketing start
- 2024-03-01
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 10 mg/1
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 834022 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-260-01 | KETOROLAC TROMETHAMINE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-260 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [LEADING PHARMA, LLC] | 8 | Current NDC, 1 package rows | 20240312_04df9620-6dcb-494a-83e2-6d28036be974.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69315-260-01 | 69315026001 | 100 TABLET, FILM COATED in 1 BOTTLE (69315-260-01) | 2024-03-01 | No | No | Historical |