Acamprosate Calcium
- Product NDC
- 0615-8560
- 11-digit product format
- 006158560
- Labeler code
- 0615
- Product ID
- 0615-8560_190e50c0-f4c7-408b-b3b3-99c0b3647164
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acamprosate calcium enteric-coated
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA200142
- Marketing category
- ANDA
- Marketing start
- 2014-09-24
- Substance
- ACAMPROSATE CALCIUM
- Active strength
- 333 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acamprosate Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACAMPROSATE CALCIUM | 333 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 59375N1D0U |
| Rxcui | 835726 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8560-39 | Acamprosate Calcium | 30 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8560 | ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 1 package rows | 20250223_f2bf6742-4b85-45e2-8daa-0f9bfc75a128.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8560-39 | 00615856039 | 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8560-39) | 2025-02-18 | No | No | Historical |