Calcium Acetate

Product NDC
50268-148
11-digit product format
502680148
Labeler code
50268
Product ID
50268-148_9caa07c2-e90d-23b9-e053-2a95a90a71be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA201658
Marketing category
ANDA
Marketing start
2015-11-16
Marketing end
0000-00-00
Substance
CALCIUM ACETATE
Active strength
667 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct50268-148DDiscontinued by firm2026-08-17
excluded packagepackage50268-14850268-148-15DDiscontinued by firm2026-08-17

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 packagepackage50268-148-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50268-148-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50268-148-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50268-148-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50268-148-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50268-148-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50268-148-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50268-148-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50268-148-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50268-148-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50268-148-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50268-148-15557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A201658-001CALCIUM ACETATECALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201658-001CALCIUM ACETATE667MGCAPSULE / ORALAB2014-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201658-001CALCIUM ACETATE667MGCAPSULE / ORALAB2014-10-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A201658-001CALCIUM ACETATE667MGCAPSULE / ORALAB2014-10-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201658-001CALCIUM ACETATE667MGCAPSULE / ORALAB2014-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201658-001CALCIUM ACETATE667MGCAPSULE / ORALAB2014-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201658-001CALCIUM ACETATE667MGCAPSULE / ORALAB2014-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09A201658-001CALCIUM ACETATE667MGCAPSULE / ORALAB2014-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A201658-001CALCIUM ACETATE667MGCAPSULE / ORALAB2014-10-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201658-001CALCIUM ACETATE667MGCAPSULE / ORAL2014-10-06e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A201658-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201658-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201658-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201658-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201658-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201658-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201658-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201658-001AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-148-11EA - Each50268-14876a0ce95-8241-4e98-82da-bd6d681c326b12015-12-02
50268-148-15EA - Each50268-1486417c366-0205-418d-9b10-89637b96537d12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
GELATININACTIVE INGREDIENT2G86QN327LCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
SHELLACINACTIVE INGREDIENT46N107B71OCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [AVPAK]1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium AcetateCALCIUM ACETATEAmneal Pharmaceuticals of New York LLC4a490e1d-80ee-461f-aba6-01f54fe8a5fe2020-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201658
application number: ANDA201658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-148-155026801481550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-148-15) > 1 CAPSULE in 1 BLISTER PACK (50268-148-11) 50 blister pack2015-11-160000-00-00NoNoCurrent