Prescription drug · ANDA
Ketorolac Tromethamine NDC 67296-2171
Ketorolac tromethamine 10 mg/1 · Tablet, Film coated · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2171-1 | 6729621710167296217101 | 20 TABLET, FILM COATED in 1 BOTTLE (67296-2171-1)Marketed from Mar 10, 2023 | |
| 67296-2171-2 | 6729621710267296217102 | 10 TABLET, FILM COATED in 1 BOTTLE (67296-2171-2)Marketed from Mar 10, 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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216759
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 67296-2171_3b0ad5fe-5943-a868-e063-6294a90aa786SPL ID 3b0ad5fe-5943-a868-e063-6294a90aa786SPL set ID 3b0aaf7f-c2fe-83c6-e063-6294a90a6f27RxCUI 834022UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467296217101followed by a unit qualifier and the quantityPackage 67296-2171-01. 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 tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac tromethamine tablets are 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 ketorolac tromethamine tablets are to be used only as continuation…
Excerpt only. Read the full label for complete information.
About NDC 67296-2171
- What is NDC 67296-2171?
- 67296-2171 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by Redpharm Drug. 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?
- Redpharm Drug, NDC labeler code 67296. 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 216759
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 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7265 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-704 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8701 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-275 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4161 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2444 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-555 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-248 |