Prescription drug · ANDA

Ketorolac Tromethamine NDC 71205-582

Ketorolac tromethamine 30 mg/mL · Injection, Solution · Intramuscular, Intravenous · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-582Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0582Add 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
71205-582-01712050582011 VIAL, SINGLE-DOSE in 1 CARTON (71205-582-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 12, 2021

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 — 30 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204216
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 71205-582_014ba8d7-7ed3-4d4a-847a-22b65161117eSPL ID 014ba8d7-7ed3-4d4a-847a-22b65161117eSPL set ID 014ba8d7-7ed3-4d4a-847a-22b65161117eRxCUI 1665461UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N471205058201 followed by a unit qualifier and the quantity

Package 71205-0582-01. 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 and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Acute Pain in Adult Patients Ketorolac tromethamine is 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 oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined du…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204216

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

FDA NDC Directory listings under ANDA 204216
ProductStrengthForm · routeLabelerProduct NDC
ketorolac tromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousFOSUN PHARMA USA INC72266-234
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousREMEDYREPACK INC.70518-4237
ketorolac tromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscularREMEDYREPACK INC.70518-3800
ketorolac tromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscularSportpharm LLC85766-017
Ketorolac tromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousA-S Medication Solutions50090-5428
Ketorolac tromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousMedical Purchasing Solutions, LLC71872-7213
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousSagent Pharmaceuticals25021-701
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousSagent Pharmaceuticals25021-700
Ketorolac tromethamineKetorolac tromethamine 60 mg/2mLInjection, SolutionIntramuscularMedical Purchasing Solutions, LLC71872-7288
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousA-S Medication Solutions50090-5609
ketorolac tromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscularProPharma Distribution84549-119
Ketorolac tromethamineKetorolac tromethamine 60 mg/2mLInjection, SolutionIntramuscularAsclemed USA, Inc.76420-272
Ketorolac tromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousHenry Schein, Inc.0404-9996
Ketorolac tromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscularHenry Schein, Inc.0404-9997
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousHenry Schein, Inc.0404-9998
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscularDirect_rx72189-583
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousCivica, Inc.72572-356
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousCivica, Inc.72572-357
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousProPharma Distribution84549-701
ketorolac tromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousGland Pharma Limited68083-132

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