Calcium Chloride

Product NDC
52584-631
11-digit product format
525840631
Labeler code
52584
Product ID
52584-631_307ef405-b3db-4aab-b385-676c5330d021
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
NDA021117
Marketing category
NDA
Marketing start
2010-07-01
Marketing end
2024-01-01
Substance
CALCIUM CHLORIDE
Active strength
100 mg/mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct52584-631DDiscontinued by firm2026-08-11
excluded packagepackage52584-63152584-631-10DDiscontinued 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 · 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 packagepackage52584-631-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52584-631-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52584-631-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52584-631-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52584-631-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52584-631-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52584-631-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52584-631-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52584-631-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52584-631-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52584-631-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52584-631-10557ba5c1ecfa…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
N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINERCALCIUM CHLORIDE100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021117-001AP

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 UTC2026-02N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28cb3db0bc1861…

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 UTC2026-02N021117-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021117-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021117-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021117-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021117-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021117-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021117-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021117-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021117-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021117-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021117-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021117-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021117-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021117-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021117-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021117-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021117-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021117-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021117-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021117-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021117-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N021117-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021117-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021117-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021117-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N021117-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021117-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021117-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021117-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021117-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021117-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021117-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021117-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021117-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021117-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021117-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021117-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021117-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021117-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021117-001AP1cb3db0bc1861…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Calcium ChlorideACTIVE INGREDIENTM4I0D6VV5MCALCIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
Calcium CationACTIVE MOIETY2M83C4R6ZBCALCIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium ChlorideCALCIUM CHLORIDEHospira, Inc.c4c65e48-85f8-4dcf-6281-06e40959cc792026-02-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021117
application number: NDA021117
Calcium ChlorideCALCIUM CHLORIDEHenry Schein, Inc.0a3b8e0e-efb0-465b-84cb-d120b3096ebd2025-10-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021117
application number: NDA021117
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta9500f41-8041-d753-e053-2a95a90a6f3c2024-02-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 021117
application number: NDA021117
Calcium ChlorideCALCIUM CHLORIDEMedical Purchasing Solutions, LLC6685165a-0df7-0ae0-e053-2a91aa0a3f222023-05-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021117
application number: NDA021117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-631-10525840631101 SYRINGE, PLASTIC in 1 BAG (52584-631-10) > 10 mL in 1 SYRINGE, PLASTIC2010-07-012024-01-01NoNoCurrent