Prescription drug · UNAPPROVED DRUG OTHER
Toronova SUIK (Ketorolac tromethamine) NDC 76420-250
Ketorolac tromethamine 30 mg/mL · Injection, Solution · Intramuscular, Intravenous · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-250-01 | 7642002500176420025001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-250-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 23, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Toronova SUIK
- Generic name (nonproprietary)
- ketorolac tromethamine
- Active ingredients
- Ketorolac tromethamine — 30 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-250_47d99edc-46e9-f065-e063-6294a90a5c70SPL ID 47d99edc-46e9-f065-e063-6294a90a5c70SPL set ID e0ed6947-5520-403b-bc0e-1caa95ab3302UNII 4EVE5946BQ
- Pharmacologic class
- Cyclooxygenase Inhibitor; Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N476420025001followed by a unit qualifier and the quantityPackage 76420-0250-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. T…
Excerpt only. Read the full label for complete information.
About NDC 76420-250
- What is NDC 76420-250?
- 76420-250 is the product NDC for Toronova SUIK (ketorolac tromethamine), Ketorolac tromethamine 30 mg/mL injection, solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Toronova SUIK (Ketorolac Tromethamine).
- What is the active ingredient?
- Ketorolac tromethamine.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Toronova SUIK?
- 1 other product NDC are listed under this name. See all Toronova SUIK NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Toronova SUIK products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Toronova SUIKketorolac tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Advanced Rx of Tennessee, LLC | 80425-0455 | 80425-0455-01 |