NDC codes

FDA NDC Directory
Product NDC (as listed)55150-340Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0340Add 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
55150-340-01551500340011 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 20, 2020
55150-340-105515003401010 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-10) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 20, 2020
55150-340-255515003402525 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-25) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 20, 2020

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 tromethamine30 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212939
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 55150-340_74f71a7a-b89a-4ad2-a19d-4f2fb87b040fSPL ID 74f71a7a-b89a-4ad2-a19d-4f2fb87b040fSPL set ID f520978f-9046-4ff8-b04d-0f615fdeae4dRxCUI 860092, 1665459, 1665461UNII 4EVE5946BQUPC 0355150340019, 0355150341016, 0355150339013
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

N455150034001 followed by a unit qualifier and the quantity

Package 55150-0340-01. 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 intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. T

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212939

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

FDA NDC Directory listings under ANDA 212939
ProductStrengthForm · routeLabelerProduct NDC
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousEugia US LLC55150-339
Ketorolac TromethamineKetorolac tromethamine 60 mg/2mLInjection, SolutionIntramuscularEugia US LLC55150-341

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