NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1532Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1532Add 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
51662-1532-15166215320110 mL in 1 VIAL, SINGLE-DOSE (51662-1532-1)Marketed from Jun 20, 2021
51662-1532-35166215320310 POUCH in 1 CASE (51662-1532-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1532-2) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 20, 2021

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)
Tranexamic Acid
Generic name (nonproprietary)
tranexamic acid
Active ingredients
Tranexamic acid100 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205035
Marketing start
Listing expires
Other FDA classes
Decreased Fibrinolysis (Physiologic effect)
Identifiers
Product ID 51662-1532_1035853c-6cb9-76b2-e063-6394a90a3938SPL ID 1035853c-6cb9-76b2-e063-6394a90a3938SPL set ID c53e2b38-6c49-acae-e053-2995a90ae9dfRxCUI 238720UNII 6T84R30KC1
Pharmacologic class
Antifibrinolytic Agent

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

N451662153201 followed by a unit qualifier and the quantity

Package 51662-1532-01. 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 .

Indications (excerpt from the label)

Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205035

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

FDA NDC Directory listings under ANDA 205035
ProductStrengthForm · routeLabelerProduct NDC
Tranexamic AcidTranexamic acid 100 mg/mLInjection, SolutionIntravenousEugia US LLC55150-188

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