Calcium Acetate

Product NDC
0781-2081
11-digit product format
007812081
Labeler code
0781
Product ID
0781-2081_ecf8e9e7-faa4-431b-e053-2995a90a3e36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021160
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-03-14
Marketing end
0000-00-00
Substance
CALCIUM ACETATE
Active strength
667 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct0781-2081DDiscontinued by firm2026-08-11
excluded packagepackage0781-20810781-2081-02DDiscontinued by firm2026-08-11

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 · 18 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 packagepackage0781-2081-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2081-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2081-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2081-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2081-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2081-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2081-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2081-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2081-020efc9e666f02…f202fb6c5f17…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2081-02EA - Each0781-20815d2f985c-25b3-4f70-9a11-23a410487a0612013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE CAPSULE [SANDOZ INC]6
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE CAPSULE [SANDOZ INC]6
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 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2081-0200781208102200 CAPSULE in 1 BOTTLE (0781-2081-02) 200 capsule2012-03-140000-00-00NoNoCurrent