NDC codes

FDA NDC Directory
Product NDC (as listed)72789-437Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0437Add 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
72789-437-0172789043701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-01)Marketed from Oct 4, 2024
72789-437-107278904371010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-10)Marketed from Nov 11, 2024
72789-437-207278904372020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-20)Marketed from Oct 10, 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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215745
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 72789-437_3a25208f-aeec-f466-e063-6294a90a92adSPL ID 3a25208f-aeec-f466-e063-6294a90a92adSPL set ID 862dd7b7-8ed5-42bf-870e-a45b86740226RxCUI 834022UNII 4EVE5946BQUPC 0372789437101
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

N472789043701 followed by a unit qualifier and the quantity

Package 72789-0437-01. 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)

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 necessa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72789-437

What is NDC 72789-437?
72789-437 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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?
179 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 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, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation43066-05143066-0051-10
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation43066-04943066-0049-10
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscularBaxter Healthcare Corporation43066-05343066-0053-10
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
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousCivica, Inc.72572-35672572-0356-25
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousCivica, Inc.72572-35772572-0357-25

All 180 Ketorolac Tromethamine NDCs

Other NDCs under ANDA 215745

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

FDA NDC Directory listings under ANDA 215745
ProductStrengthForm · routeLabelerProduct NDC
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralLeading Pharma, LLC69315-260

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