Prescription drug · ANDA

Ketorolac Tromethamine NDC 71335-2444

Ketorolac tromethamine 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2444Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2444Add 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
71335-2444-071335244400713352444003 TABLET, FILM COATED in 1 BOTTLE (71335-2444-0)Marketed from Jul 15, 2024
71335-2444-1713352444017133524440130 TABLET, FILM COATED in 1 BOTTLE (71335-2444-1)Marketed from Jul 15, 2024
71335-2444-2713352444027133524440210 TABLET, FILM COATED in 1 BOTTLE (71335-2444-2)Marketed from Jul 15, 2024
71335-2444-3713352444037133524440320 TABLET, FILM COATED in 1 BOTTLE (71335-2444-3)Marketed from Jul 15, 2024
71335-2444-4713352444047133524440490 TABLET, FILM COATED in 1 BOTTLE (71335-2444-4)Marketed from Jul 15, 2024
71335-2444-5713352444057133524440516 TABLET, FILM COATED in 1 BOTTLE (71335-2444-5)Marketed from Jul 15, 2024
71335-2444-671335244406713352444068 TABLET, FILM COATED in 1 BOTTLE (71335-2444-6)Marketed from Jul 15, 2024
71335-2444-7713352444077133524440715 TABLET, FILM COATED in 1 BOTTLE (71335-2444-7)Marketed from Jul 15, 2024
71335-2444-871335244408713352444085 TABLET, FILM COATED in 1 BOTTLE (71335-2444-8)Marketed from Jul 15, 2024
71335-2444-97133524440971335244409100 TABLET, FILM COATED in 1 BOTTLE (71335-2444-9)Marketed from Jul 15, 2024

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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216759
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 71335-2444_3531818e-2753-d40a-e063-6394a90a117bSPL ID 3531818e-2753-d40a-e063-6394a90a117bSPL set ID 8f36fde8-bc59-4a59-8659-b173cfd15774RxCUI 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

N471335244400 followed by a unit qualifier and the quantity

Package 71335-2444-00. 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 intravenous or intramuscular dosing of ketorolac tromethamine, and ketorolac tromethamine tablets are to be used only as continuation…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2444

What is NDC 71335-2444?
71335-2444 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 216759

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

FDA NDC Directory listings under ANDA 216759
ProductStrengthForm · routeLabelerProduct NDC
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7265
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-704
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralRedpharm Drug67296-2171
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8701
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralBionpharma Inc.69452-275
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4161
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralDirect_Rx72189-555
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralProficient Rx LP82804-248

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