Ketorolac Tromethamine
- Product NDC
- 82868-020
- 11-digit product format
- 828680020
- Labeler code
- 82868
- Product ID
- 82868-020_47fc7966-9df4-e94b-e063-6394a90a3461
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA215788
- Marketing category
- ANDA
- Marketing start
- 2023-10-19
- 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
- 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 | 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 |
|---|
| 82868-020-15 | Ketorolac Tromethamine | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 3 |
| 82868-020-20 | Ketorolac Tromethamine | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-020 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20240110_08674066-7d4b-936d-e063-6394a90abbd7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-020-15 | 82868002015 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-15) | 2023-10-19 | No | No | Historical |
| 82868-020-20 | 82868002020 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-20) | 2023-11-14 | No | No | Historical |