Application 088912

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	9MG/ML	No	Yes
002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	180MG/20ML (9MG/ML)	No	Yes
003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	270MG/30ML (9MG/ML)	No	Yes
004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	18MG/2ML (9MG/ML)	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10
A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10
A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10
A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A088912-001	AP
A088912-002	AP
A088912-003	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 3 · 112 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
2026-09-14 22:38:34	2026-08	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088912-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088912-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	180MG/20ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088912-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	RS	1985-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088912-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	18MG/2ML (9MG/ML)	SOLUTION / INJECTION		RS	1985-11-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 89 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088912-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088912-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088912-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088912-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088912-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088912-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A088912-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A088912-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088912-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088912-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088912-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088912-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088912-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088912-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088912-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088912-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088912-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088912-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088912-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088912-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088912-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088912-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088912-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088912-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088912-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A088912-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A088912-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088912-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A088912-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A088912-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088912-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088912-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088912-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088912-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088912-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088912-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088912-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088912-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088912-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088912-001	AP	1	`3f0d92c62455…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Cardinal Health 107, LLC	97007188-43fe-416c-a87b-6ccc4d9ae2ec	2025-10-29	Adverse reactions	Exact identifier application applno (ANDA): 088912 application number: ANDA088912 ndc (product): 55154-9357
Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	e0466bb3-6c26-4044-b051-69f48b67f632	2025-08-07	Adverse reactions	Exact identifier application applno (ANDA): 088912 application number: ANDA088912 ndc (product): 0404-9955
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	f62481fd-fcdb-4be6-ac13-29c590e925c3	2022-02-10	Adverse reactions	Exact identifier application applno (ANDA): 088912 application number: ANDA088912 ndc (product): 63323-186

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9955	Sodium Chloride	Sodium Chloride	Henry Schein, Inc.	ANDA	Current
0404-9955	Sodium Chloride	Sodium Chloride	Henry Schein, Inc.	ANDA	Current
50090-2488	Sodium Chloride	SODIUM CHLORIDE	A-S Medication Solutions	ANDA	Current
50090-2488	Sodium Chloride	SODIUM CHLORIDE	A-S Medication Solutions	ANDA	Current
50090-2488	Sodium Chloride	SODIUM CHLORIDE	A-S Medication Solutions	ANDA	Current
52584-186	Sodium Chloride	Sodium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-186	Sodium Chloride	Sodium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-186	Sodium Chloride	Sodium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-186	Sodium Chloride	Sodium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-186	Sodium Chloride	Sodium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-186	Sodium Chloride	Sodium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-186	Sodium Chloride	Sodium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
55154-9357	Sodium Chloride	SODIUM CHLORIDE	Cardinal Health	ANDA	Current
55154-9357	Sodium Chloride	SODIUM CHLORIDE	Cardinal Health	ANDA	Current
55154-9357	Sodium Chloride	SODIUM CHLORIDE	Cardinal Health	ANDA	Current
55154-9357	Sodium Chloride	SODIUM CHLORIDE	Cardinal Health 107, LLC	ANDA	Current
55154-9357	Sodium Chloride	SODIUM CHLORIDE	Cardinal Health	ANDA	Current
55154-9357	Sodium Chloride	SODIUM CHLORIDE	Cardinal Health 107, LLC	ANDA	Current
63323-186	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-186	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-186	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-186	Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
70518-1425	Sodium Chloride	SODIUM CHLORIDE	REMEDYREPACK INC.	ANDA	Current