Prescription drug · ANDA
Ketorolac Tromethamine NDC 83270-157
Ketorolac tromethamine 15 mg/mL · Injection · Intramuscular, Intravenous · Onesource Specialty Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83270-157-01 | 83270015701 | 1 SYRINGE, GLASS in 1 CARTON (83270-157-01) / 1 mL in 1 SYRINGE, GLASSMarketed from Sep 30, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201155
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 83270-157_45964863-b614-400a-e063-6294a90ac151SPL ID 45964863-b614-400a-e063-6294a90ac151SPL set ID 4596483b-990b-eaa4-e063-6394a90ac08fRxCUI 860113, 860114, 860115UNII 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
N483270015701followed by a unit qualifier and the quantityPackage 83270-0157-01. 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.
Other NDCs under ANDA 201155
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 | Onesource Specialty Pharma Limited | 83270-158 |
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | InjectionIntramuscular | Onesource Specialty Pharma Limited | 83270-159 |