Application 212441

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	No	No
002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE / INJECTION	AP		2020-07-24
A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE / INJECTION	AP		2020-07-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212441-001	AP
A212441-002	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 · 76 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
2026-08-18 06:07:40	2026-07	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212441-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212441-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	2020-07-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212441-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212441-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212441-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212441-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212441-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212441-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212441-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212441-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212441-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212441-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212441-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212441-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212441-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212441-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212441-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212441-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212441-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212441-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212441-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212441-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212441-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212441-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212441-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212441-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212441-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212441-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212441-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212441-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212441-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212441-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212441-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212441-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212441-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212441-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212441-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212441-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212441-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212441-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212441-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212441-002	AP	1	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	25b0ba06-3274-4a3f-8c39-42d13764ecdf	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212441 application number: ANDA212441 ndc (product): 63323-519

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-519	Heparin Sodium	Heparin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-519	Heparin Sodium	Heparin Sodium	Fresenius Kabi USA, LLC	ANDA	Current
66298-5191	Heparin Sodium	Heparin Sodium	Fresenius Kabi Norge AS	ANDA	Current
66298-5197	Heparin Sodium	Heparin Sodium	Fresenius Kabi Norge AS	ANDA	Current