What is NDC 63323-162?

63323-162 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 30 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 63323-162

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-162Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0162Add 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	Copy
63323-162-12	6332301621263323016212	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-162-12) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-162-23)Marketed from Oct 18, 2000
63323-162-14	6332301621463323016214	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-162-14) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-162-25)Marketed from Oct 18, 2000

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 — 30 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075784
Marketing start: Oct 18, 2000
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 63323-162_55ed7afb-db66-4b28-939b-db45b55bf058SPL ID 55ed7afb-db66-4b28-939b-db45b55bf058SPL set ID 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9RxCUI 860092, 1665459, 1665461UNII 4EVE5946BQUPC 0363323161217, 0363323162238, 0363323162252
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323016212 followed by a unit qualifier and the quantity

Package 63323-0162-12. 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 Nov 18, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Acute Pain in Adult Patients Ketorolac tromethamine is 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 oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. T…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-162

What is NDC 63323-162?: 63323-162 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 30 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. 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?: Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 075784

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

FDA NDC Directory listings under ANDA 075784
Product	Strength	Form · route	Labeler	Product NDC
Ketorolac Tromethamine	Ketorolac tromethamine 30 mg/mL	Injection, SolutionIntramuscular	HF Acquisition Co LLC, DBA HealthFirst	51662-1594
Ketorolac Tromethamine	Ketorolac tromethamine 30 mg/mL	Injection, SolutionIntramuscular	HF Acquisition Co LLC, DBA HealthFirst	51662-1702
Ketorolac Tromethamine	Ketorolac tromethamine 15 mg/mL	Injection, SolutionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-9366
Ketorolac Tromethamine	Ketorolac tromethamine 30 mg/mL	Injection, SolutionIntramuscular	Cardinal Health 107, LLC	55154-9368
Ketorolac Tromethamine	Ketorolac tromethamine 30 mg/mL	Injection, SolutionIntramuscular	Cardinal Health 107, LLC	55154-9398
Ketorolac Tromethamine	Ketorolac tromethamine 15 mg/mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-161
Ketorolac Tromethamine	Ketorolac tromethamine 30 mg/mL	Injection, SolutionIntramuscular	Medical Purchasing Solutions, LLC	71872-7185