Application 212248

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 23.4%	SODIUM CHLORIDE	INJECTABLE;INJECTION	234MG/ML	No	No

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 ndc (product): 0404-9978
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 ndc (product): 63323-093

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9978	SODIUM CHLORIDE	sodium chloride	Henry Schein, Inc.	ANDA	Current
0404-9978	SODIUM CHLORIDE	sodium chloride	Henry Schein, Inc.	ANDA	Current
52584-109	SODIUM CHLORIDE	sodium chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-109	SODIUM CHLORIDE	sodium chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-109	SODIUM CHLORIDE	sodium chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-109	SODIUM CHLORIDE	sodium chloride	General Injectables and Vaccines, Inc.	ANDA	Current
63323-093	Sodium Chloride	Sodium Chloride	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67453	ORIG	2021-05-11