NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7303Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7303Add 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
0904-7303-04009047303040090473030430 BLISTER PACK in 1 CARTON (0904-7303-04) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 30, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215788
Marketing start
Marketing end
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0904-7303_c3e25550-bc2b-4c8f-96bb-61c3e2e28608SPL ID c3e25550-bc2b-4c8f-96bb-61c3e2e28608SPL set ID 48245718-a2df-4938-8d06-3b8abf34181eRxCUI 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

N400904730304 followed by a unit qualifier and the quantity

Package 00904-7303-04. 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 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 trea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7303

What is NDC 0904-7303?
0904-7303 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, 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?
Major Pharmaceuticals, NDC labeler code 0904. 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 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 coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0267
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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