Prescription drug · ANDA
Acamprosate Calcium (Acamprosate calcium enteric-coated) NDC 0378-6333
Acamprosate calcium 333 mg/1 · Tablet, Delayed release · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-6333-80 | 00378633380 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)Marketed from Sep 24, 2014 |
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
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200142
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-6333_e06868f1-f40b-4762-bd52-53a5ba825619SPL ID e06868f1-f40b-4762-bd52-53a5ba825619SPL set ID 75ddfd10-55b2-426e-bc74-3413cd0d7c94RxCUI 835726UNII 59375N1D0UUPC 0303786333806
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
N400378633380followed by a unit qualifier and the quantityPackage 00378-6333-80. 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.
About NDC 0378-6333
- What is NDC 0378-6333?
- 0378-6333 is the product NDC for Acamprosate Calcium (acamprosate calcium enteric-coated), Acamprosate calcium 333 mg/1 tablet, delayed release, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acamprosate Calcium (Acamprosate calcium enteric-coated).
- What is the active ingredient?
- Acamprosate calcium.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 | Somerset Therapeutics, LLC | 70069-860 | 70069-0860-1870069-0860-30 |
| 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 | 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 |
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8560 |