What is NDC 80425-0489?

80425-0489 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ketorolac Tromethamine NDC 80425-0489 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0489Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0489Add 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
80425-0489-1	80425048901	9 TABLET, FILM COATED in 1 BOTTLE (80425-0489-1)Marketed from Jan 30, 2025
80425-0489-2	80425048902	10 TABLET, FILM COATED in 1 BOTTLE (80425-0489-2)Marketed from Jan 30, 2025
80425-0489-3	80425048903	20 TABLET, FILM COATED in 1 BOTTLE (80425-0489-3)Marketed from Jan 30, 2025
80425-0489-4	80425048904	30 TABLET, FILM COATED in 1 BOTTLE (80425-0489-4)Marketed from Jan 30, 2025
80425-0489-5	80425048905	60 TABLET, FILM COATED in 1 BOTTLE (80425-0489-5)Marketed from Jan 30, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216651
Marketing start: Jan 30, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 80425-0489_2cf758ae-264f-cb5a-e063-6394a90aab02SPL ID 2cf758ae-264f-cb5a-e063-6394a90aab02SPL set ID 2cf7516b-ac86-ca72-e063-6394a90a4339RxCUI 834022UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425048901 followed by a unit qualifier and the quantity

Package 80425-0489-01. 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 Jan 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets are 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 IV or IM dosing of ketorolac tromethamine, and Ketorolac Tromethamine Tablets are to be used only as continuation treatment, if necess…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0489

What is NDC 80425-0489?: 80425-0489 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 5 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?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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.

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 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

All 177 Ketorolac Tromethamine NDCs

Other NDCs under ANDA 216651

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

FDA NDC Directory listings under ANDA 216651
Product	Strength	Form · route	Labeler	Product NDC
Ketorolac Tromethamine	Ketorolac tromethamine 10 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-686
Ketorolac Tromethamine	Ketorolac tromethamine 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7695
Ketorolac Tromethamine	Ketorolac tromethamine 10 mg/1	Tablet, Film coatedOral	Injecta Medcial LLC	87234-7695