Prescription drug · ANDA
Ketorolac Tromethamine NDC 61314-126
Ketorolac tromethamine 5 mg/mL · Solution · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-126-05 | 61314012605 | 1 BOTTLE in 1 CARTON (61314-126-05) / 5 mL in 1 BOTTLEMarketed from Nov 5, 2009 | |
| 61314-126-10 | 61314012610 | 1 BOTTLE in 1 CARTON (61314-126-10) / 10 mL in 1 BOTTLEMarketed from Nov 5, 2009 |
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
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076583
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 61314-126_2833a9fe-4416-4012-8d2c-c9d5090fd2e7SPL ID 2833a9fe-4416-4012-8d2c-c9d5090fd2e7SPL set ID 79e29a86-1b44-4d95-8d84-5a2e8f23ddcfRxCUI 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
N461314012605followed by a unit qualifier and the quantityPackage 61314-0126-05. 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 temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory drug (NSAID) indicated for: • The temporary relief of ocular itching due to seasonal allergic conjunctivitis. ( 1 ) • The treatment of inflammation following cataract surgery. ( 1 ) •
Excerpt only. Read the full label for complete information.
About NDC 61314-126
- What is NDC 61314-126?
- 61314-126 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 5 mg/mL solution, listed with the FDA by Sandoz Inc. 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?
- Sandoz Inc, NDC labeler code 61314. 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 |
Other NDCs under ANDA 076583
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 | A-S Medication Solutions | 50090-2746 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-2252 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | SolutionOphthalmic | Proficient Rx LP | 71205-296 |