Prescription drug · ANDA

Ketorolac Tromethamine NDC 80425-0267

Ketorolac tromethamine 10 mg/1 · Tablet, Film coated · Oral · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0267Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0267Add 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 NDC11-digit (billing)PackageCopy
80425-0267-180425026701804250267019 TABLET, FILM COATED in 1 BOTTLE (80425-0267-1)Marketed from Feb 17, 2023
80425-0267-2804250267028042502670220 TABLET, FILM COATED in 1 BOTTLE (80425-0267-2)Marketed from Feb 17, 2023
80425-0267-3804250267038042502670330 TABLET, FILM COATED in 1 BOTTLE (80425-0267-3)Marketed from Feb 17, 2023
80425-0267-4804250267048042502670460 TABLET, FILM COATED in 1 BOTTLE (80425-0267-4)Marketed from Feb 17, 2023
80425-0267-5804250267058042502670510 TABLET, FILM COATED in 1 BOTTLE (80425-0267-5)Marketed from Mar 30, 2023

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 Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215788
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 80425-0267_2a9ad9e4-1654-c0dc-e063-6294a90a6e45SPL ID 2a9ad9e4-1654-c0dc-e063-6294a90a6e45SPL set ID f4e7f1c8-e458-0860-e053-2a95a90a1bf0RxCUI 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

N480425026701 followed by a unit qualifier and the quantity

Package 80425-0267-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets USP 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 USP are 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 80425-0267

What is NDC 80425-0267?
80425-0267 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy 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 Pharmacy 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?
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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ketorolac TromethamineKetorolac tromethamine 60 mg/2mLInjection, SolutionIntramuscularAnthea Pharma Private Limited83854-02483854-0024-25
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousAnthea Pharma Private Limited83854-02283854-0022-25
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAmerisyn LLC87564-01887564-0018-10
ketorolac tromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-412968788-4129-0268788-4129-03
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscularBaxter Healthcare Corporation43066-05343066-0053-10
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation43066-04943066-0049-10
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation43066-05143066-0051-10
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralInjecta Medcial LLC87234-769587234-7695-02
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousCardinal Health 107, LLC55154-783355154-7833-05
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralInjecta Medcial LLC87234-769587234-7695-01

All 184 Ketorolac Tromethamine NDCs

Other NDCs under ANDA 215788

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

FDA NDC Directory listings under ANDA 215788
ProductStrengthForm · routeLabelerProduct NDC
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAjanta Pharma USA Inc.27241-316
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAmerisyn LLC87564-018
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7303
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7453
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-677
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralRedpharm Drug67296-2163
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2658
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8891
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralDR. REDDY'S LABORATORIES, INC.43598-139
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2136
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-020
ketorolac tromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAmici Pharma Inc.69292-650
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7638

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