Acamprosate Calcium
- Product NDC
- 60687-121
- 11-digit product format
- 606870121
- Labeler code
- 60687
- Product ID
- 60687-121_3d49a773-bfca-9870-e063-6294a90a2945
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acamprosate Calcium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA202229
- Marketing category
- ANDA
- Marketing start
- 2015-10-27
- 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 |
|---|
| 60687-121-25 | Acamprosate Calcium | 30 in 1 BOX, UNIT-DOSE | TABLET, DELAYED RELEASE | 30 | | 11 |
| 60687-121-95 | Acamprosate Calcium | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACAMPROSATE CALCIUM | ACTIVE INGREDIENT | 59375N1D0U | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| ACAMPROSATE | ACTIVE MOIETY | N4K14YGM3J | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| MAGNESIUM SILICATE | INACTIVE INGREDIENT | 9B9691B2N9 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-121 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241003_94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8.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 |
|---|
| 60687-121-25 | 60687012125 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-121-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-121-95) | 30 blister pack | 2015-10-27 | 0000-00-00 | No | No | Current |
| 60687-121-95 | 60687012195 | 1 in 1 BLISTER PACK | | | | | | Historical |