Prescription drug · ANDA
Ketorolac Tromethamine NDC 72189-335
Ketorolac tromethamine 5 mg/mL · Solution · Ophthalmic · Direct Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-335-05 | 7218903350572189033505 | 5 mL in 1 BOTTLE (72189-335-05)Marketed from Mar 7, 2022 |
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 — 5 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Direct RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203410
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-335_2c3d8ffc-3ef5-cfa1-e063-6394a90a868eSPL ID 2c3d8ffc-3ef5-cfa1-e063-6394a90a868eSPL set ID d9a589b4-bd32-0e45-e053-2a95a90ae67dRxCUI 860107UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472189033505followed by a unit qualifier and the quantityPackage 72189-0335-05. 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 .
Indications (excerpt from the label)
Before you use Ketorolac Tromethamine Ophthalmic solution 0.5% for the first time: 1.Check to make sure that the tamper evident ring between the bottle and the cap is not broken ( See Figure A). If the tamper evident ring is broken or missing, contact your pharmacist. [Img-fig-a] 2.Tear off the tamper evident ring ( See Figure B). [Img-fig-b] 3.To open the bottle, remove the cap by turning it in the counterclockwise direction ( See Figure C). [Img-fig-c] This Instructions for Use has been approved by the U.S. Food and Drug Administration. Rev.10/2021
Excerpt only. Read the full label for complete information.
About NDC 72189-335
- What is NDC 72189-335?
- 72189-335 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 5 mg/mL solution, listed with the FDA by Direct Rx. 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?
- Direct Rx, NDC labeler code 72189. 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 203410
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 5 mg/mL | SolutionOphthalmic | Micro Labs Limited | 42571-137 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | SolutionOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8549 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | SolutionOphthalmic | Bryant Ranch Prepack | 72162-2384 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-301 |