Prescription drug · ANDA

Ketorolac Tromethamine NDC 63187-128

Ketorolac tromethamine 10 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-128Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0128Add 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
63187-128-10631870128106318701281010 TABLET, FILM COATED in 1 BOTTLE (63187-128-10)Marketed from Mar 1, 2021
63187-128-12631870128126318701281212 TABLET, FILM COATED in 1 BOTTLE (63187-128-12)Marketed from Feb 8, 2022
63187-128-15631870128156318701281515 TABLET, FILM COATED in 1 BOTTLE (63187-128-15)Marketed from Jun 1, 2016
63187-128-20631870128206318701282020 TABLET, FILM COATED in 1 BOTTLE (63187-128-20)Marketed from Jul 6, 2014
63187-128-30631870128306318701283030 TABLET, FILM COATED in 1 BOTTLE (63187-128-30)Marketed from Jun 1, 2016
63187-128-60631870128606318701286060 TABLET, FILM COATED in 1 BOTTLE (63187-128-60)Marketed from Jun 1, 2016
63187-128-90631870128906318701289090 TABLET, FILM COATED in 1 BOTTLE (63187-128-90)Marketed from Jun 1, 2016

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
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074754
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63187-128_dd66f622-8f11-4a86-a70c-9a9a8300fda5SPL ID dd66f622-8f11-4a86-a70c-9a9a8300fda5SPL set ID f5170993-81a9-4eb7-95ac-60697a5ee1d7RxCUI 834022UNII 4EVE5946BQUPC 0363187128104
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

N463187012810 followed by a unit qualifier and the quantity

Package 63187-0128-10. 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 63187-128

What is NDC 63187-128?
63187-128 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 7 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?
Proficient Rx LP, NDC labeler code 63187. 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 074754

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

FDA NDC Directory listings under ANDA 074754
ProductStrengthForm · routeLabelerProduct NDC
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-0314
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-904
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0601
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-170
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-104
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-2974
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.66267-418
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.66267-832
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0048
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-032
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0139
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralSportpharm LLC85766-035

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