Ketorolac Tromethamine
- Product NDC
- 82804-248
- 11-digit product format
- 828040248
- Labeler code
- 82804
- Product ID
- 82804-248_38fc11a0-50d1-4ba5-8d46-331eb74a00d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA216759
- Marketing category
- ANDA
- Marketing start
- 2023-03-10
- 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 |
|---|
| 82804-248-15 | Ketorolac Tromethamine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 82804-248-20 | Ketorolac Tromethamine | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-248-15 | 82804024815 | 15 TABLET, FILM COATED in 1 BOTTLE (82804-248-15) | 2025-10-15 | No | No | Current |
| 82804-248-20 | 82804024820 | 20 TABLET, FILM COATED in 1 BOTTLE (82804-248-20) | 2025-10-15 | No | No | Current |