Calcium Acetate

Product NDC
53808-0905
11-digit product format
538080905
Labeler code
53808
Product ID
53808-0905_19ef92d2-2d50-4b5e-ae22-7d734ca29f15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021160
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-01
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
2019-12-31
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 productproduct53808-0905IInactivated by FDA2026-08-11
excluded packagepackage53808-090553808-0905-1IInactivated by FDA2026-08-11

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 · 42 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 packagepackage53808-0905-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0905-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0905-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0905-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0905-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0905-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0905-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0905-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0905-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0905-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0905-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0905-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0905-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0905-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0905-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0905-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0905-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0905-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0905-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0905-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0905-19bebd1f3094a…5416666fcb17…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021160-001PHOSLOCALCIUM ACETATE333.5MGCAPSULE / ORAL2001-04-02
N021160-002PHOSLOCALCIUM ACETATE667MGCAPSULE / ORAL2001-04-02
N021160-003PHOSLO GELCAPSCALCIUM ACETATE667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-04-02

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021160-003PHOSLO GELCAPS667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021160-003PHOSLO GELCAPS667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021160-003PHOSLO GELCAPS667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021160-002PHOSLO667MGCAPSULE / ORAL2001-04-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021160-003PHOSLO GELCAPS667MGCAPSULE / ORALRLD2001-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021160-001PHOSLO333.5MGCAPSULE / ORAL2001-04-028072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021160-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021160-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021160-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021160-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021160-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021160-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021160-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021160-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021160-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021160-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021160-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021160-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021160-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021160-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021160-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021160-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021160-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021160-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021160-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021160-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021160-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021160-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021160-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021160-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021160-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021160-003AB1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021160-00265766652021-04-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021160-00365766652021-04-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021160-00368754452021-07-30Drug product2015-03-1774a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021160-00265766652021-04-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N021160-00365766652021-04-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N021160-00368754452021-07-30Drug product2015-03-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021160-00265766652021-04-0387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021160-00365766652021-04-0387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021160-00368754452021-07-30Drug product2015-03-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N021160-00265766652021-04-035aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021160-00365766652021-04-035aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021160-00368754452021-07-30Drug product2015-03-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021160-00265766652021-04-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021160-00365766652021-04-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021160-00368754452021-07-30Drug product2015-03-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021160-00265766652021-04-03c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021160-00365766652021-04-03c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021160-00368754452021-07-30Drug product2015-03-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021160-00265766652021-04-033f01610625f2…
2019-12-14 00:12 UTC2019-12N021160-00365766652021-04-033f01610625f2…
2019-12-14 00:12 UTC2019-12N021160-00368754452021-07-30Drug product2015-03-173f01610625f2…
2019-09-15 20:21 UTC2019-09N021160-00265766652021-04-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N021160-00365766652021-04-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N021160-00368754452021-07-30Drug product2015-03-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N021160-00265766652021-04-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N021160-00365766652021-04-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N021160-00368754452021-07-30Drug product2015-03-17ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0905-1Calcium Acetate30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0905CALCIUM ACETATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141007_b02f8473-3220-4651-9c7f-993645f43a82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSNb02f8473-3220-4651-9c7f-993645f43a821
359296calcium acetate 667 MG Oral CapsuleSCDb02f8473-3220-4651-9c7f-993645f43a821
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSYb02f8473-3220-4651-9c7f-993645f43a821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0905-15380809050130 in 1 BLISTER PACKHistorical