Calcium Chloride

Product NDC: 52584-631
Requested package NDC: 52584-631-10
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52584-631	52584-631-10	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	CALCIUM CHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021117-001	CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2000-01-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021117-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021117-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021117-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021117-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021117-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021117-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021117-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021117-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021117-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021117-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021117-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021117-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021117-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021117-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021117-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021117-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021117-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021117-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021117-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021117-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021117-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021117-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021117-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021117-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021117-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021117-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021117-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021117-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021117-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021117-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021117-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021117-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021117-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021117-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021117-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021117-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021117-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021117-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021117-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021117-001	AP	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Calcium Chloride	ACTIVE INGREDIENT	M4I0D6VV5M	CALCIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	4
Calcium Cation	ACTIVE MOIETY	2M83C4R6ZB	CALCIUM 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcium Chloride	CALCIUM CHLORIDE	Hospira, Inc.	c4c65e48-85f8-4dcf-6281-06e40959cc79	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021117 application number: NDA021117
Calcium Chloride	CALCIUM CHLORIDE	Henry Schein, Inc.	0a3b8e0e-efb0-465b-84cb-d120b3096ebd	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021117 application number: NDA021117
CALCIUM CHLORIDE	CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a9500f41-8041-d753-e053-2a95a90a6f3c	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021117 application number: NDA021117
Calcium Chloride	CALCIUM CHLORIDE	Medical Purchasing Solutions, LLC	6685165a-0df7-0ae0-e053-2a91aa0a3f22	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021117 application number: NDA021117

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M4I0D6VV5M	CALCIUM CHLORIDE	10035-04-8	CALCIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-631-10	52584063110	1 SYRINGE, PLASTIC in 1 BAG (52584-631-10) > 10 mL in 1 SYRINGE, PLASTIC	2010-07-01	2024-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
10% Calcium Chloride 100 mg/mL Injection, USP 10 mL PreFilled Syringe	General Injectables & Vaccines, Inc	2022-12-12	HUMAN PRESCRIPTION DRUG LABEL	12