Prescription drug · ANDA
Ketorolac Tromethamine NDC 50090-6772
Ketorolac tromethamine 60 mg/2mL · Injection · Intramuscular, Intravenous · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6772-0 | 5009067720050090677200 | 25 VIAL in 1 CARTON (50090-6772-0) / 2 mL in 1 VIALMarketed from Oct 24, 2023 | |
| 50090-6772-1 | 5009067720150090677201 | 1 VIAL in 1 CARTON (50090-6772-1) / 2 mL in 1 VIALMarketed from Oct 24, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 60 mg/2mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214456
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-6772_43eb6809-9fcc-46d2-8b92-13dfff0599d0SPL ID 43eb6809-9fcc-46d2-8b92-13dfff0599d0SPL set ID 3321b610-1c9b-4314-adbb-a2e163234decRxCUI 1665459UNII 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
N450090677200followed by a unit qualifier and the quantityPackage 50090-6772-00. 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 50090-6772
- What is NDC 50090-6772?
- 50090-6772 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 60 mg/2mL injection, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 214456
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 | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7327 |
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7328 |
| Ketorolac Tromethamine | Ketorolac tromethamine 15 mg/mL | InjectionIntramuscular, Intravenous | A-S Medication Solutions | 50090-6807 |
| Ketorolac Tromethamine | Ketorolac tromethamine 15 mg/mL | InjectionIntramuscular, Intravenous | Alembic Pharmaceuticals Inc. | 62332-599 |
| Ketorolac Tromethamine | Ketorolac tromethamine 15 mg/mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-049 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | InjectionIntramuscular, Intravenous | Alembic Pharmaceuticals Inc. | 62332-600 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-051 |
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | InjectionIntramuscular, Intravenous | Alembic Pharmaceuticals Inc. | 62332-601 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | Injection, SolutionIntramuscular | Baxter Healthcare Corporation | 43066-053 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | InjectionIntramuscular, Intravenous | Sportpharm LLC | 85766-298 |
| Ketorolac Tromethamine | Ketorolac tromethamine 15 mg/mL | InjectionIntramuscular, Intravenous | Sportpharm LLC | 85766-297 |
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | InjectionIntramuscular, Intravenous | Sportpharm LLC | 85766-299 |
| Ketorolac Tromethamine | Ketorolac tromethamine 30 mg/mL | InjectionIntramuscular, Intravenous | Sportpharm LLC | 85766-064 |