Prescription drug · ANDA
Dehydrated Alcohol (Alcohol) NDC 55579-306
Alcohol 1 mL/mL · Injection · Percutaneous · Solupharm Pharmazeutische Erzeugnisse GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55579-306-05 | 5557903060555579030605 | 5 mL in 1 BOX (55579-306-05)Marketed from Jan 8, 2025 | |
| 55579-306-41 | 5557903064155579030641 | 5 mL in 1 VIAL, SINGLE-USE (55579-306-41)Marketed from Jan 8, 2025 |
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)
- Dehydrated Alcohol
- Generic name (nonproprietary)
- alcohol
- Active ingredients
- Alcohol — 1 mL/mL
- Dosage form
- Injection
- Route
- Percutaneous
- Labeler
- Solupharm Pharmazeutische Erzeugnisse GmbHNDC labeler code 55579
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219569
- Marketing start
- Listing expires
- Identifiers
- Product ID 55579-306_462e1f5b-024d-3dcb-e063-6294a90a9520SPL ID 462e1f5b-024d-3dcb-e063-6294a90a9520SPL set ID 372d3eb5-78ee-414c-a146-4a19e2266184RxCUI 2048982UNII 3K9958V90M
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.
- NDC on a medical claim
N455579030605followed by a unit qualifier and the quantityPackage 55579-0306-05. 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)
Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. Dehydrated alcohol injection is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 55579-306
- What is NDC 55579-306?
- 55579-306 is the product NDC for Dehydrated Alcohol (alcohol), Alcohol 1 mL/mL injection, listed with the FDA by Solupharm Pharmazeutische Erzeugnisse GmbH. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dehydrated Alcohol (Alcohol).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- Solupharm Pharmazeutische Erzeugnisse GmbH, NDC labeler code 55579. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dehydrated Alcohol?
- 9 other product NDCs are listed under this name. See all Dehydrated Alcohol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dehydrated Alcohol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionIntra-arterial | Breckenridge Pharmaceutical Inc | 51991-999 | 51991-0999-17 |
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionPercutaneous | Ajenat Pharmaceuticals LLC | 82983-426 | 82983-0426-10 |
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionPercutaneous | Avenacy, LLC | 83634-306 | 83634-0306-0583634-0306-06 |
| Dehydrated Alcohol | Dehydrated alcohol 5 mL/5mL | Injection, SolutionPercutaneous | Ingenus Pharmaceuticals, LLC | 50742-539 | 50742-0539-10 |
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionPercutaneous | Accord Healthcare, Inc. | 16729-710 | 16729-0710-4516729-0710-53 |
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionPercutaneous | XGen Pharmaceuticals DJB, Inc. | 39822-9300 | 39822-9300-02 |
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionPercutaneous | A-S Medication Solutions | 50090-7643 | 50090-7643-0050090-7643-01 |
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionPercutaneous | BPI Labs, LLC | 54288-144 | 54288-0144-10 |
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionPercutaneous | BPI Labs, LLC | 54288-105 | 54288-0105-1054288-0105-15 |
Other NDCs under ANDA 219569
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 |
|---|---|---|---|---|
| Dehydrated Alcohol | Dehydrated alcohol 5 mL/5mL | Injection, SolutionPercutaneous | Ingenus Pharmaceuticals, LLC | 50742-539 |
| Dehydrated Alcoholalcohol | Alcohol 1 mL/mL | Injection, SolutionPercutaneous | Avenacy, LLC | 83634-306 |