Prescription drug · ANDA
acamprosate calcium NDC 70518-4616
Acamprosate calcium 333 mg/1 · Tablet, Delayed release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4616-0 | 70518461600 | 50 POUCH in 1 BOX (70518-4616-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-4616-1)Marketed from Apr 23, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Acamprosate calcium — 333 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205995
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4616_5216f438-5ac5-eb94-e063-6394a90a5d5cSPL ID 5216f438-5ac5-eb94-e063-6394a90a5d5cSPL set ID 91769a96-3182-4e38-90c3-b22c1beae398RxCUI 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
N470518461600followed by a unit qualifier and the quantityPackage 70518-4616-00. 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)
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 ( 1 , 14 ). Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ( 1 ). 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 aca…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205995
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 calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Zydus Lifesciences Limited | 70771-1057 |
| acamprosate calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-569 |