Prescription drug · ANDA
Ketorolac Tromethamine NDC 70512-842
Ketorolac tromethamine 15 mg/mL · Injection · Intramuscular, Intravenous · SOLA Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70512-842-25 | 7051208422570512084225 | 25 VIAL in 1 CARTON (70512-842-25) / 1 mL in 1 VIAL (70512-842-01)Marketed from Jul 1, 2023 |
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)
- Ketorolac Tromethamine
- Generic name (nonproprietary)
- ketorolac tromethamine
- Active ingredients
- Ketorolac tromethamine — 15 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- SOLA Pharmaceuticals, LLCNDC labeler code 70512
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217789
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70512-842_457271ef-6508-6596-e063-6394a90a039dSPL ID 457271ef-6508-6596-e063-6394a90a039dSPL set ID 2301a6a2-b88a-4c0d-bb6c-ad4a8af7da39RxCUI 860092, 1665459, 1665461UNII 4EVE5946BQUPC 0370512844011, 0370512844257
- 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
N470512084225followed by a unit qualifier and the quantityPackage 70512-0842-25. 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 70512-842
- What is NDC 70512-842?
- 70512-842 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 15 mg/mL injection, listed with the FDA by SOLA Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ketorolac Tromethamine.
- What is the active ingredient?
- Ketorolac tromethamine.
- Who is the labeler?
- SOLA Pharmaceuticals, LLC, NDC labeler code 70512. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ketorolac Tromethamine?
- 183 other product NDCs are listed under this name. See all Ketorolac Tromethamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ketorolac Tromethamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | Injection, SolutionIntramuscular | Anthea Pharma Private Limited | 83854-024 | 83854-0024-25 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Anthea Pharma Private Limited | 83854-022 | 83854-0022-25 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Amerisyn LLC | 87564-018 | 87564-0018-10 |
| ketorolac tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4129 | 68788-4129-0268788-4129-03 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular | Baxter Healthcare Corporation | 43066-053 | 43066-0053-10 |
| Ketorolac Tromethamine | Ketorolac tromethamine 15 mg/mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-049 | 43066-0049-10 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-051 | 43066-0051-10 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Injecta Medcial LLC | 87234-7695 | 87234-7695-02 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-7833 | 55154-7833-05 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Injecta Medcial LLC | 87234-7695 | 87234-7695-01 |
Other NDCs under ANDA 217789
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-145 |
| Ketorolac Tromethamine | Ketorolac tromethamine 15 mg/mL | Injection, SolutionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-146 |
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | Injection, SolutionIntramuscular | Caplin Steriles Limited | 65145-147 |
| Ketorolac Tromethamine | Ketorolac tromethamine 15 mg/mL | Injection, SolutionIntramuscular, Intravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-755 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-756 |
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | Injection, SolutionIntramuscular | GLENMARK PHARMACEUTICALS INC., USA | 68462-757 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | InjectionIntramuscular, Intravenous | SOLA Pharmaceuticals, LLC | 70512-843 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | InjectionIntramuscular, Intravenous | SOLA Pharmaceuticals, LLC | 70512-844 |
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | Injection, SolutionIntramuscular | REMEDYREPACK INC. | 70518-4253 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7363 |