Campral

Product NDC
68151-4760
11-digit product format
681514760
Labeler code
68151
Product ID
68151-4760_e6f9c308-7699-48ef-8c70-c69e938521eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acamprosate calcium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021431
Marketing category
NDA
Marketing start
2005-01-11
Marketing end
0000-00-00
Substance
ACAMPROSATE CALCIUM
Active strength
333 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-4760IInactivated by FDA2026-08-03
excluded packagepackage68151-476068151-4760-0DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 34 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68151-4760-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68151-4760-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68151-4760-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68151-4760-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68151-4760-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68151-4760-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-4760-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-4760-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-4760-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-4760-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-4760-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-4760-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021431-001CAMPRALACAMPROSATE CALCIUM333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021431-001CAMPRAL333MGTABLET, DELAYED RELEASE / ORALRLD2004-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021431-001CAMPRAL333MGTABLET, DELAYED RELEASE / ORALRLD2004-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c95d5956-8a83-9dba-bb9d-d7b5fb3324ecProduct name320170724

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4760-0Campral1 in 1 PACKAGETABLET, DELAYED RELEASE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
acamprosate calciumACTIVE INGREDIENT59375N1D0UCAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
acamprosateACTIVE MOIETYN4K14YGM3JCAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9CAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JCAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4760CAMPRAL (ACAMPROSATE CALCIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160808_fe6f754f-62b4-4c86-805d-221332409516.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSNfe6f754f-62b4-4c86-805d-2213324095163
835728Campral 333 MG Delayed Release Oral TabletPSNfe6f754f-62b4-4c86-805d-2213324095163
835728acamprosate calcium 333 MG Delayed Release Oral Tablet [Campral]SBDfe6f754f-62b4-4c86-805d-2213324095163
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCDfe6f754f-62b4-4c86-805d-2213324095163
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSYfe6f754f-62b4-4c86-805d-2213324095163
835728Campral 333 MG (equivalent to acamprosate 300 MG) Delayed Release Oral TabletSYfe6f754f-62b4-4c86-805d-2213324095163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4760-0681514760001 in 1 PACKAGEHistorical