CALCIUM ACETATE

Product NDC
50436-0621
11-digit product format
504360621
Labeler code
50436
Product ID
50436-0621_a090f7ac-fc26-452b-b88d-29d3bf8edbba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CALCIUM ACETATE
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA202885
Marketing category
ANDA
Marketing start
2012-02-23
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
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 productproduct50436-0621IInactivated by FDA2026-08-11
excluded packagepackage50436-062150436-0621-1IInactivated 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 · 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 packagepackage50436-0621-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-0621-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-0621-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-0621-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-0621-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-0621-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-0621-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-0621-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-0621-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-0621-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-0621-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-0621-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-0621-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-0621-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-0621-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-0621-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-0621-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-0621-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-0621-18dfbde2a14a4…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
A202885-001CALCIUM ACETATECALCIUM ACETATE667MGTABLET / ORALAB2015-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202885-001AB

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 UTC2026-02A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-223f01610625f2…
2019-09-15 20:21 UTC2019-09A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202885-001CALCIUM ACETATE667MGTABLET / ORALAB2015-01-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202885-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202885-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202885-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202885-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202885-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202885-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202885-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202885-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202885-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202885-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202885-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202885-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202885-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202885-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202885-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202885-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202885-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202885-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202885-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202885-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202885-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202885-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202885-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202885-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202885-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202885-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202885-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202885-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202885-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202885-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202885-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202885-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202885-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202885-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202885-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202885-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202885-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202885-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202885-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202885-001AB1cb3db0bc1861…

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
50436-0621-1CALCIUM ACETATE50 in 1 BOX, UNIT-DOSETABLET502
50436-0621-1CALCIUM ACETATE1 in 1 POUCHTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0621CALCIUM ACETATE TABLET [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20180404_6c6fa6c8-1ea2-4558-87a0-dfd98b0c80c9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CALCIUM ACETATECALCIUM ACETATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ac4975aa-0ee9-4473-81e2-839f1556e6842023-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202885
application number: ANDA202885

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197433calcium 169 MG Oral Tablet, as calcium acetatePSN6c6fa6c8-1ea2-4558-87a0-dfd98b0c80c92
197433calcium acetate 667 MG Oral TabletSCD6c6fa6c8-1ea2-4558-87a0-dfd98b0c80c92
197433calcium acetate 667 MG (calcium 169 MG) Oral TabletSY6c6fa6c8-1ea2-4558-87a0-dfd98b0c80c92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0621-15043606210150 in 1 BOX, UNIT-DOSEHistorical