acamprosate calcium
- Product NDC
- 70518-4616
- 11-digit product format
- 705184616
- Labeler code
- 70518
- Product ID
- 70518-4616_5216f438-5ac5-eb94-e063-6394a90a5d5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acamprosate calcium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205995
- Marketing category
- ANDA
- Marketing start
- 2026-04-23
- Substance
- ACAMPROSATE CALCIUM
- Active strength
- 333 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- acamprosate calcium
- Listing expiration
- 2027-12-31
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 |
|---|
| 70518-4616-0 | acamprosate calcium | 50 in 1 BOX | TABLET, DELAYED RELEASE | 50 | | 1 |
| 70518-4616-1 | acamprosate calcium | 1 in 1 POUCH | TABLET, DELAYED RELEASE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4616-0 | 70518461600 | 50 POUCH in 1 BOX (70518-4616-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-4616-1) | 50 pouch | 2026-04-23 | No | No | Historical |
| 70518-4616-1 | 70518461601 | 1 in 1 POUCH | | | | | Historical |