Prescription drug · ANDA
Acamprosate Calcium (acamprosate calcium enteric-coated) NDC 0615-8560
Acamprosate calcium 333 mg/1 · Tablet, Delayed release · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8560-39 | 00615856039 | 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8560-39)Marketed from Feb 18, 2025 |
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)
- Acamprosate Calcium
- Generic name (nonproprietary)
- acamprosate calcium enteric-coated
- Active ingredients
- Acamprosate calcium — 333 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200142
- Marketing start
- Marketing end
- Identifiers
- Product ID 0615-8560_603358e6-47cf-41ab-87eb-bd9f26670844SPL ID 603358e6-47cf-41ab-87eb-bd9f26670844SPL set ID f2bf6742-4b85-45e2-8daa-0f9bfc75a128RxCUI 835726UNII 59375N1D0U
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400615856039followed by a unit qualifier and the quantityPackage 00615-8560-39. 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)
Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200142
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 |
|---|---|---|---|---|
| Acamprosate Calciumacamprosate calcium enteric-coated | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Mylan Pharmaceuticals Inc. | 0378-6333 |