What is NDC 69315-322?

69315-322 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 5 mg/mL solution/ drops, listed with the FDA by Leading Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ketorolac Tromethamine NDC 69315-322

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-322Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0322Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
69315-322-03	6931503220369315032203	1 BOTTLE, DROPPER in 1 CARTON (69315-322-03) / 3 mL in 1 BOTTLE, DROPPERMarketed from Jun 1, 2024
69315-322-05	6931503220569315032205	1 BOTTLE, DROPPER in 1 CARTON (69315-322-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jun 1, 2024
69315-322-10	6931503221069315032210	1 BOTTLE, DROPPER in 1 CARTON (69315-322-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Jun 1, 2024

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/ drops
Route: Ophthalmic
Labeler: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218204
Marketing start: Jun 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 69315-322_11be552b-2427-4cd7-a81d-f0ae5063d3f6SPL ID 11be552b-2427-4cd7-a81d-f0ae5063d3f6SPL set ID c34b69c6-5cdf-41f6-8652-33bd8e9c6c70RxCUI 860107UNII 4EVE5946BQUPC 0369315322109, 0369315322031, 0369315322055
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

N469315032203 followed by a unit qualifier and the quantity

Package 69315-0322-03. 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 May 24, 2024.

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 indicated for: The treatment of inflammation following cataract surgery. ( 1 ) The temporary relief of ocular itching due to seasonal allergic conjunctivitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-322

What is NDC 69315-322?: 69315-322 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 5 mg/mL solution/ drops, listed with the FDA by Leading Pharma, LLC. It has 3 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?: Leading Pharma, LLC, NDC labeler code 69315. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ketorolac Tromethamine NDCs
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

All 184 Ketorolac Tromethamine NDCs

Other NDCs under ANDA 218204

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218204
Product	Strength	Form · route	Labeler	Product NDC
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-138
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-139
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-140
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	SolutionOphthalmic	Redpharm Drug	67296-2210
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	Redpharm Drug	67296-2253
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	Redpharm Drug	67296-2318
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals, Inc.	68071-3684
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	SolutionOphthalmic	SOLA Pharmaceuticals, LLC	70512-790