Prescription drug · NDA
Cyklokapron (Tranexamic acid) NDC 0013-1114
Tranexamic acid 100 mg/mL · Injection, Solution · Intravenous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0013-1114-15 | 0001311141500013111415 | 1 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01)Marketed from Nov 21, 2018 | |
| 0013-1114-21 | 0001311142100013111421 | 10 VIAL in 1 BOX (0013-1114-21) / 10 mL in 1 VIAL (0013-1114-20)Marketed from Dec 30, 1986 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Cyklokapron
- Generic name (nonproprietary)
- tranexamic acid
- Active ingredients
- Tranexamic acid — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0013
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019281
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 0013-1114_9776ef50-2235-40ba-9245-de06f7b4d019SPL ID 9776ef50-2235-40ba-9245-de06f7b4d019SPL set ID 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5RxCUI 208104, 238720UNII 6T84R30KC1UPC 0300131114103
- 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.
- NDC on a medical claim
N400013111415followed by a unit qualifier and the quantityPackage 00013-1114-15. 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)
CYKLOKAPRON ® 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. CYKLOKAPRON is an antifibrinolytic 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. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0013-1114
- What is NDC 0013-1114?
- 0013-1114 is the product NDC for Cyklokapron (tranexamic acid), Tranexamic acid 100 mg/mL injection, solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyklokapron (Tranexamic acid).
- What is the active ingredient?
- Tranexamic acid.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0013. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyklokapron?
- 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.