Prescription drug · ANDA
Acamprosate Calcium NDC 70069-860
Acamprosate calcium 333 mg/1 · Tablet, Delayed release · Oral · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-860-18 | 7006908601870069086018 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (70069-860-18)Marketed from Aug 10, 2026 | |
| 70069-860-30 | 7006908603070069086030 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (70069-860-30)Marketed from Aug 10, 2026 |
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)
- Acamprosate Calcium
- Generic name (nonproprietary)
- acamprosate calcium
- Active ingredients
- Acamprosate calcium — 333 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218984
- Marketing start
- Listing expires
- Identifiers
- Product ID 70069-860_1cfe4675-766f-4f1a-b1a8-96bbdacfcfa5SPL ID 1cfe4675-766f-4f1a-b1a8-96bbdacfcfa5SPL set ID 1cfe4675-766f-4f1a-b1a8-96bbdacfcfa5RxCUI 835726UNII 59375N1D0UUPC 0370069860182, 0370069860304
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
N470069086018followed by a unit qualifier and the quantityPackage 70069-0860-18. 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 is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium treatment. The efficacy of acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. Acamprosate calcium delayed-release tablets are indicated for t…
Excerpt only. Read the full label for complete information.
About NDC 70069-860
- What is NDC 70069-860?
- 70069-860 is the product NDC for Acamprosate Calcium, Acamprosate calcium 333 mg/1 tablet, delayed release, listed with the FDA by Somerset Therapeutics, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acamprosate Calcium.
- What is the active ingredient?
- Acamprosate calcium.
- Who is the labeler?
- Somerset Therapeutics, LLC, NDC labeler code 70069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acamprosate Calcium?
- 10 other product NDCs are listed under this name. See all Acamprosate Calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acamprosate Calcium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| acamprosate calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-4616 | 70518-4616-00 |
| Acamprosate Calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8660 | 00615-8660-39 |
| Acamprosate Calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Bionpharma Inc., | 69452-353 | 69452-0353-25 |
| acamprosate calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-569 | 68382-0569-0168382-0569-0568382-0569-06+3 more |
| acamprosate calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Zydus Lifesciences Limited | 70771-1057 | 70771-1057-0070771-1057-0170771-1057-03+3 more |
| Acamprosate Calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-121 | 60687-0121-25 |
| Acamprosate Calciumacamprosate calcium enteric-coated | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Mylan Pharmaceuticals Inc. | 0378-6333 | 00378-6333-80 |
| Acamprosate Calciumacamprosate calcium enteric-coated | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8560 | 00615-8560-39 |
| Acamprosate Calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Major Pharmaceuticals | 0904-7213 | 00904-7213-04 |
| Acamprosate Calcium | Acamprosate calcium 333 mg/1 | Tablet, Delayed releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-435 | 68462-0435-1168462-0435-18 |