Prescription drug · NDA
Cortrosyn (Cosyntropin) NDC 0548-5900
Cosyntropin .25 mg/mL · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Amphastar Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0548-5900-00 | 0054859000000548590000 | 10 VIAL in 1 CARTON (0548-5900-00) / 1 mL in 1 VIALMarketed from Aug 1, 2003 |
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)
- Cortrosyn
- Generic name (nonproprietary)
- cosyntropin
- Active ingredients
- Cosyntropin — .25 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Amphastar Pharmaceuticals, Inc.NDC labeler code 0548
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016750
- Marketing start
- Listing expires
- Other FDA classes
- Adrenocorticotropic Hormone (Chemical structure)
- Identifiers
- Product ID 0548-5900_089a373b-a63a-4575-8065-fdef2fc6c575SPL ID 089a373b-a63a-4575-8065-fdef2fc6c575SPL set ID 746856e9-3930-4f6a-b8e6-a03845d6dd0bUNII 72YY86EA29
- Pharmacologic class
- Adrenocorticotropic Hormone
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
N400548590000followed by a unit qualifier and the quantityPackage 00548-5900-00. 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)
CORTROSYN is indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients. CORTROSYN is an adrenocorticotropin hormone indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients.
Excerpt only. Read the full label for complete information.
About NDC 0548-5900
- What is NDC 0548-5900?
- 0548-5900 is the product NDC for Cortrosyn (cosyntropin), Cosyntropin .25 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Amphastar Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cortrosyn (Cosyntropin).
- What is the active ingredient?
- Cosyntropin.
- Who is the labeler?
- Amphastar Pharmaceuticals, Inc., NDC labeler code 0548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cortrosyn?
- 2 other product NDCs are listed under this name. See all Cortrosyn NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cortrosyn products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cortrosyn | Cosyntropin .25 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Parenteral | Henry Schein, Inc. | 0404-9839 | 00404-9839-99 |
| Cortrosyncosyntropin | Cosyntropin .25 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7318 | 71872-7318-01 |
Other NDCs under NDA 016750
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cortrosyn | Cosyntropin .25 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Parenteral | Henry Schein, Inc. | 0404-9839 |
| Cortrosyncosyntropin | Cosyntropin .25 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7318 |