Acamprosate Calcium
- Product NDC
- 69452-353
- 11-digit product format
- 694520353
- Labeler code
- 69452
- Product ID
- 69452-353_44732224-b730-9a24-e063-6394a90ac0c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acamprosate Calcium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bionpharma Inc.,
- Application
- ANDA219904
- Marketing category
- ANDA
- Marketing start
- 2025-12-01
- 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 |
|---|
| 69452-353-25 | Acamprosate Calcium | 180 in 1 BOTTLE | TABLET, DELAYED RELEASE | 180 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69452-353-25 | 69452035325 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25) | 2025-12-01 | No | No | Current |