Acamprosate Calcium
- Product NDC
- 0904-7213
- 11-digit product format
- 009047213
- Labeler code
- 0904
- Product ID
- 0904-7213_70a2162f-c686-46f6-9fe2-6c2e4f36fc21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acamprosate Calcium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA202229
- Marketing category
- ANDA
- Marketing start
- 2013-07-16
- 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 |
|---|
| 0904-7213-04 | Acamprosate Calcium | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | | 4 |
| 0904-7213-04 | Acamprosate Calcium | 30 in 1 CARTON | TABLET, DELAYED RELEASE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7213 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241018_ae6e79c0-a307-4888-b647-1b7be4cb9127.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7213-04 | 00904721304 | 30 BLISTER PACK in 1 CARTON (0904-7213-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 30 blister pack | 2013-07-16 | 0000-00-00 | No | No | Current |