FDA.reportPublic FDA data

leader acid reducer complete

Product NDC
70000-0316
11-digit product format
700000316
Labeler code
70000
Product ID
70000-0316_bcc0ccbc-3efb-47d0-9007-afcfb7626fed
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine, calcium carbonate, magnesium hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA204782
Marketing category
ANDA
Marketing start
2020-01-15
Marketing end
0000-00-00
Substance
FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
Active strength
10 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct70000-0316DDiscontinued by firm2026-08-10
excluded packagepackage70000-031670000-0316-1DDiscontinued by firm2026-08-10

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 · 24 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 packagepackage70000-0316-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70000-0316-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70000-0316-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70000-0316-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70000-0316-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70000-0316-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70000-0316-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70000-0316-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70000-0316-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70000-0316-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70000-0316-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70000-0316-1557ba5c1ecfa…9c80585c8c6e…

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
A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDECALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29

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 UTC2026-02A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-293f01610625f2…
2019-09-15 20:21 UTC2019-09A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204782-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2016-08-29cb3db0bc1861…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0316-17000003160125 TABLET, CHEWABLE in 1 BOTTLE (70000-0316-1) 2020-01-150000-00-00NoNoCurrent