NDC codes

FDA NDC Directory
Product NDC (as listed)83854-021Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83854-0021Add 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
83854-021-108385400211010 VIAL in 1 CARTON (83854-021-10) / 1 mL in 1 VIAL (83854-021-01)Marketed from Sep 25, 2026
83854-021-258385400212525 VIAL in 1 CARTON (83854-021-25) / 1 mL in 1 VIAL (83854-021-01)Marketed from Sep 25, 2026

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)
Ketrolac Tromethamine
Generic name (nonproprietary)
ketorolac tromethamine
Active ingredients
Ketorolac tromethamine — 15 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous
Labeler
Anthea Pharma Private LimitedNDC labeler code 83854
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 221041
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 83854-021_5c9999ae-45e2-b2e5-e063-6294a90a87f6SPL ID 5c9999ae-45e2-b2e5-e063-6294a90a87f6
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

N483854002110 followed by a unit qualifier and the quantity

Package 83854-0021-10. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 83854-021

What is NDC 83854-021?
83854-021 is the product NDC for Ketrolac Tromethamine (ketorolac tromethamine), Ketorolac tromethamine 15 mg/mL injection, solution, listed with the FDA by Anthea Pharma Private Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ketrolac Tromethamine (Ketorolac tromethamine).
What is the active ingredient?
Ketorolac tromethamine.
Who is the labeler?
Anthea Pharma Private Limited, NDC labeler code 83854. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ketrolac Tromethamine?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 221041

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

FDA NDC Directory listings under ANDA 221041
ProductStrengthForm · routeLabelerProduct NDC
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousAnthea Pharma Private Limited83854-022
Ketorolac TromethamineKetorolac tromethamine 60 mg/2mLInjection, SolutionIntramuscularAnthea Pharma Private Limited83854-024

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