Acamprosate Calcium

Product NDC
10135-636
11-digit product format
101350636
Labeler code
10135
Product ID
10135-636_c9c9c07d-25f5-40e2-b40a-1d1942dd640a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acamprosate Calcium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA202229
Marketing category
ANDA
Marketing start
2016-08-01
Marketing end
0000-00-00
Substance
ACAMPROSATE CALCIUM
Active strength
333 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct10135-636IInactivated by FDA2026-08-03
excluded packagepackage10135-63610135-636-32IInactivated by FDA2026-08-03

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10135-636-32d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10135-636-32f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10135-636-322ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10135-636-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10135-636-32cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10135-636-32cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10135-636-32302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10135-636-32ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10135-636-320efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10135-636-32ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10135-636-32367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10135-636-32557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10135-636-328af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10135-636-32834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10135-636-321332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10135-636-32fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10135-636-3286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10135-636-32bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10135-636-328dfbde2a14a4…c9ff85d89658…

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
A202229-001ACAMPROSATE CALCIUMACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202229-001AB

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 UTC2026-02A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALAB2013-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORAL2013-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORAL2013-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORAL2013-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORAL2013-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORAL2013-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORAL2013-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORAL2013-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-163f01610625f2…
2019-09-15 20:21 UTC2019-09A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202229-001ACAMPROSATE CALCIUM333MGTABLET, DELAYED RELEASE / ORALABRS2013-07-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202229-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202229-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202229-001AB16a471c1ec25d…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202229-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202229-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202229-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202229-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202229-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202229-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202229-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202229-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202229-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202229-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202229-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202229-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202229-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202229-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202229-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202229-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202229-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202229-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202229-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202229-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202229-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202229-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202229-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202229-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202229-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202229-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202229-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202229-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202229-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202229-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202229-001AB1a50c72e98297…

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
10135-636-32Acamprosate Calcium180 in 1 BOTTLETABLET, DELAYED RELEASE1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-636ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 1 package rows20191112_a815699f-90ee-41ba-838c-11951aeda90f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acamprosate CalciumACAMPROSATE CALCIUMMajor Pharmaceuticalsae6e79c0-a307-4888-b647-1b7be4cb91272026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202229
application number: ANDA202229
Acamprosate CalciumACAMPROSATE CALCIUMGlenmark Pharmaceuticals Inc., USA43e9ef60-2d85-4394-906b-93042fea099a2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202229
application number: ANDA202229
Acamprosate CalciumACAMPROSATE CALCIUMAmerican Health Packaging94ef2a5c-cc2f-4e7f-b159-b2d38188d5b82025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202229
application number: ANDA202229

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSNa815699f-90ee-41ba-838c-11951aeda90f3
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCDa815699f-90ee-41ba-838c-11951aeda90f3
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSYa815699f-90ee-41ba-838c-11951aeda90f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-636-3210135063632180 in 1 BOTTLEHistorical