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NDC 00378-6333-80 Acamprosate Calcium 333 mg/1 Details
Acamprosate Calcium 333 mg/1
Acamprosate Calcium is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is ACAMPROSATE CALCIUM.
MedlinePlus Drug Summary
Acamprosate is used along with counseling and social support to help people who have stopped drinking large amounts of alcohol (alcoholism) to avoid drinking alcohol again. Drinking alcohol for a long time changes the way the brain works. Acamprosate works by helping the brains of people who have drunk large amounts of alcohol to work normally again. Acamprosate does not prevent the withdrawal symptoms that people may experience when they stop drinking alcohol. Acamprosate has not been shown to work in people who have not stopped drinking alcohol or in people who drink large amounts of alcohol and also overuse or abuse other substances such as street drugs or prescription medications.
Related Packages: 00378-6333-80Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acamprosate
Product Information
| NDC | 00378-6333 |
|---|---|
| Product ID | 0378-6333_2708a3db-e987-4dd8-9c47-db3aa8a7010e |
| Associated GPIs | 62802010200620 |
| GCN Sequence Number | 025600 |
| GCN Sequence Number Description | acamprosate calcium TABLET DR 333 MG ORAL |
| HIC3 | C0D |
| HIC3 Description | ANTI-ALCOHOLIC PREPARATIONS |
| GCN | 36441 |
| HICL Sequence Number | 010731 |
| HICL Sequence Number Description | ACAMPROSATE CALCIUM |
| Brand/Generic | Generic |
| Proprietary Name | Acamprosate Calcium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | acamprosate calcium enteric-coated |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 333 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACAMPROSATE CALCIUM |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA200142 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-6333-80 (00378633380)
| NDC Package Code | 0378-6333-80 |
|---|---|
| Billing NDC | 00378633380 |
| Package | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80) |
| Marketing Start Date | 2014-09-24 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.5192 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | ACAMPROSATE CALC DR 333 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |