Ketorolac Tromethamine
- Product NDC
- 0904-7303
- 11-digit product format
- 009047303
- Labeler code
- 0904
- Product ID
- 0904-7303_c3e25550-bc2b-4c8f-96bb-61c3e2e28608
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA215788
- Marketing category
- ANDA
- Marketing start
- 2024-08-30
- Marketing end
- 2026-11-30
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketorolac Tromethamine
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 |
|---|
| 0904-7303-04 | Ketorolac Tromethamine | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 3 |
| 0904-7303-04 | Ketorolac Tromethamine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7303 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20250119_48245718-a2df-4938-8d06-3b8abf34181e.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 |
|---|
| 0904-7303-04 | 00904730304 | 30 BLISTER PACK in 1 CARTON (0904-7303-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2024-08-30 | 2026-11-30 | No | No | Historical |