Application 207310

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	No	No

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
A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	INJECTABLE / INJECTION	AP		2017-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207310-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207310-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-09-19	`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	A207310-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207310-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207310-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207310-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207310-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207310-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207310-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207310-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207310-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207310-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207310-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207310-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207310-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207310-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207310-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207310-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207310-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207310-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207310-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207310-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207310-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207310-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207310-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207310-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207310-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207310-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207310-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207310-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207310-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207310-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207310-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207310-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207310-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207310-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207310-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207310-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207310-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207310-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207310-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207310-001	AP	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	d98bf9f7-30ec-4927-a577-cabad192cb18	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310 ndc (product): 65219-218 ndc (product): 65219-222 ndc (product): 65219-220 ndc (product): 65219-224
Sodium chloride	SODIUM CHLORIDE	BECTON DICKINSON AND COMPANY	d39b7307-df67-4e68-acb0-2eda5dc61215	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	6d43fa91-0940-437f-ba70-b2d3f977593e	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310
Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ebc8b008-a8b3-4c41-89e4-b413f7aab89f	2024-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310 ndc (product): 17271-701
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	c1e52670-c85e-4f19-a2e9-bf9abd7c3727	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310 ndc (product): 63323-623
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	037ac04d-f8f3-4bb8-993a-ac8f7683ff83	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e88	2023-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310 ndc (product): 65219-432
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4829ee40-c2d7-4e17-a606-75e8a8628413	2021-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310 ndc (product): 63323-632
0.9% SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c755e41b-acba-7234-e053-2995a90aff0f	2021-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207310 application number: ANDA207310 ndc (product): 51662-1577

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17271-701	Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ANDA	Current
17271-701	Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ANDA	Current
17271-701	Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ANDA	Current
17271-701	Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ANDA	Current
17271-701	Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ANDA	Current
51662-1577	0.9% SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-623	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-623	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-623	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-632	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-632	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-632	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-218	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-218	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-220	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-220	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-222	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-222	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-224	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-224	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-432	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-432	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current