Toronova SUIK
- Product NDC
- 80425-0455
- 11-digit product format
- 804250455
- Labeler code
- 80425
- Product ID
- 80425-0455_288893cd-4785-6ddd-e063-6394a90a7144
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Advanced Rx of Tennessee, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2024-11-20
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 30 mg/mL
- 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
- Toronova SUIK
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0455-1 | Toronova SUIK | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
| 80425-0455-1 | Toronova SUIK | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0455 | TORONOVA SUIK (KETOROLAC TROMETHAMINE) INJECTION, SOLUTION [ADVANCED RX OF TENNESSEE, LLC] | 2 | Current NDC, 2 package rows | 20241208_275f9131-5915-a585-e063-6294a90ab0fc.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0455-1 | 80425045501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (80425-0455-1) / 1 mL in 1 VIAL, SINGLE-DOSE | 2024-11-20 | No | No | Current |