SODIUM CHLORIDE

Product NDC: 52584-109
Requested package NDC: 52584-109-01
11-digit product format: 525840109
Labeler code: 52584
Product ID: 52584-109_27c4834c-bf0d-49f2-97bd-73d3a7fc5550
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium chloride
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: General Injectables and Vaccines, Inc.
Application: ANDA212248
Marketing category: ANDA
Marketing start: 2021-07-28
Marketing end: 2024-03-31
Substance: SODIUM CHLORIDE
Active strength: 4 meq/mL
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	52584-109	52584-109-01	D	Discontinued by firm		2026-08-17

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 42.

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
A212248-001	SODIUM CHLORIDE 23.4%	SODIUM CHLORIDE	234MG/ML	INJECTABLE / INJECTION	AP		2021-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212248-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION		2021-04-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212248-001	SODIUM CHLORIDE 23.4%	234MG/ML	INJECTABLE / INJECTION	AP	2021-04-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212248-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212248-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212248-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212248-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212248-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212248-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212248-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212248-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212248-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212248-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212248-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212248-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212248-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212248-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212248-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212248-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212248-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212248-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212248-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212248-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212248-001	AP	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212248-001	AP	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM CHLORIDE	SODIUM CHLORIDE	Henry Schein, Inc.	2e81ffca-05c6-4fa0-8911-4b3cbfa71351	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212248 application number: ANDA212248
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4a655cde-283f-4ec8-a3d9-5f539c55c204	2021-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212248 application number: ANDA212248

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-109-01	52584010901	1 VIAL in 1 BAG (52584-109-01) > 30 mL in 1 VIAL	1 vial	2021-07-28	2024-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Chloride	General Injectables and Vaccines, Inc.	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL	4