Prescription drug · NDA
Terlivaz (Terlipressin) NDC 43825-200
Terlipressin .85 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Mallinckrodt Hospital Products Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43825-200-01 | 43825020001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43825-200-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 14, 2022 |
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)
- Terlivaz
- Generic name (nonproprietary)
- terlipressin
- Active ingredients
- Terlipressin — .85 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Mallinckrodt Hospital Products Inc.NDC labeler code 43825
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022231
- Marketing start
- Listing expires
- Other FDA classes
- Vasopressin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43825-200_f838b29e-0369-4f88-8176-1c504ea76597SPL ID f838b29e-0369-4f88-8176-1c504ea76597SPL set ID 3a35b86c-f451-4fac-8499-43019e4da354RxCUI 2612431, 2612436UNII 7Z5X49W53P
- Pharmacologic class
- Vasopressin Receptor Agonist
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
N443825020001followed by a unit qualifier and the quantityPackage 43825-0200-01. 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)
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Limitation of Use Patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit. TERLIVAZ is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. ( 1 ) Limitation of Use Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 43825-200
- What is NDC 43825-200?
- 43825-200 is the product NDC for Terlivaz (terlipressin), Terlipressin .85 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Mallinckrodt Hospital Products Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terlivaz (Terlipressin).
- What is the active ingredient?
- Terlipressin.
- Who is the labeler?
- Mallinckrodt Hospital Products Inc., NDC labeler code 43825. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Terlivaz?
- 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.