Acamprosate Calcium
- Product NDC
- 68462-435
- 11-digit product format
- 684620435
- Labeler code
- 68462
- Product ID
- 68462-435_6560e0ea-e882-4fcd-b523-8c5474d32f91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acamprosate Calcium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- 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 |
|---|
| 68462-435-11 | Acamprosate Calcium | 10 in 1 CARTON | TABLET, DELAYED RELEASE | 10 | | 12 |
| 68462-435-11 | Acamprosate Calcium | 10 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 10 | | 12 |
| 68462-435-18 | Acamprosate Calcium | 180 in 1 BOTTLE | TABLET, DELAYED RELEASE | 180 | | 12 |
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 [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| ACAMPROSATE | ACTIVE MOIETY | N4K14YGM3J | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| MAGNESIUM SILICATE | INACTIVE INGREDIENT | 9B9691B2N9 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| 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 |
|---|
| 68462-435 | ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 11 | Current NDC, Legacy NDC, 3 package rows | 20230110_43e9ef60-2d85-4394-906b-93042fea099a.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 |
|---|
| 68462-435-11 | 68462043511 | 10 BLISTER PACK in 1 CARTON (68462-435-11) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 10 blister pack | 2013-07-16 | 0000-00-00 | No | No | Current |
| 68462-435-18 | 68462043518 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68462-435-18) | | 2013-07-16 | 0000-00-00 | No | No | Current |