Ketorolac Tromethamine
- Product NDC
- 72189-555
- 11-digit product format
- 721890555
- Labeler code
- 72189
- Product ID
- 72189-555_4c4aad0a-641f-1aa7-e063-6294a90a13da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA216759
- Marketing category
- ANDA
- Marketing start
- 2024-06-03
- 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 |
|---|
| 72189-555-10 | Ketorolac Tromethamine | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 5 |
| 72189-555-15 | Ketorolac Tromethamine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 5 |
| 72189-555-20 | Ketorolac Tromethamine | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 5 |
| 72189-555-30 | Ketorolac Tromethamine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-555 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT_RX] | 3 | Current NDC, 4 package rows | 20241004_19fffe42-a02d-26eb-e063-6294a90aea5a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-555-10 | 72189055510 | 10 TABLET, FILM COATED in 1 BOTTLE (72189-555-10) | 2024-06-03 | No | No | Current |
| 72189-555-15 | 72189055515 | 15 TABLET, FILM COATED in 1 BOTTLE (72189-555-15) | 2024-06-03 | No | No | Current |
| 72189-555-20 | 72189055520 | 20 TABLET, FILM COATED in 1 BOTTLE (72189-555-20) | 2024-06-03 | No | No | Current |
| 72189-555-30 | 72189055530 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-555-30) | 2024-06-03 | No | No | Current |