Prescription drug · ANDA
Ketorolac Tromethamine NDC 65862-775
Ketorolac tromethamine 4 mg/mL · Solution/ drops · Ophthalmic · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-775-05 | 65862077505 | 1 BOTTLE in 1 CARTON (65862-775-05) / 5 mL in 1 BOTTLEMarketed from Nov 15, 2018 |
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 — 4 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205191
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-775_ffe3b63b-abfc-455b-bc6c-49cd58e406e0SPL ID ffe3b63b-abfc-455b-bc6c-49cd58e406e0SPL set ID e93f6501-827d-474c-b660-765b7c0fb871RxCUI 860103UNII 4EVE5946BQUPC 0365862775054
- 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
N465862077505followed by a unit qualifier and the quantityPackage 65862-0775-05. 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)
Ketorolac tromethamine ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory drug (NSAID) indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. (1)
Excerpt only. Read the full label for complete information.
About NDC 65862-775
- What is NDC 65862-775?
- 65862-775 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 4 mg/mL solution/ drops, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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?
- 176 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 30 mg/mL | Injection, SolutionIntramuscular, Intravenous | Anthea Pharma Private Limited | 83854-022 | 83854-0022-25 |
| Ketorolac Tromethamine | Ketorolac tromethamine 60 mg/2mL | Injection, SolutionIntramuscular | Anthea Pharma Private Limited | 83854-024 | 83854-0024-25 |
| 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 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 30 mg/mL | Injection, SolutionIntramuscular | Baxter Healthcare Corporation | 43066-053 | 43066-0053-10 |
| 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 15 mg/mL | Injection, SolutionIntramuscular, Intravenous | Civica, Inc. | 72572-356 | 72572-0356-25 |