Heparin Sodium

Product NDC: 63323-519
11-digit product format: 633230519
Labeler code: 63323
Product ID: 63323-519_3bbbe74a-1246-41a6-9fc3-ca0230529b40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Heparin Sodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA212441
Marketing category: ANDA
Marketing start: 2020-07-24
Substance: HEPARIN SODIUM
Active strength: 200 [USP'U]/100mL
Pharmacologic classes: Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Heparin Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HEPARIN SODIUM	200 [USP'U]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZZ45AB24CA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1658690	Internal RxNorm lookup
1658692	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
25b0ba06-3274-4a3f-8c39-42d13764ecdf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac74f96-3910-44b9-8551-036880fbb1fb	Product name	1	20260108
0a18eae4-4259-42db-86b6-915f66e83b06	Product name	1	20250729
2c999b01-2a13-4eff-8eb4-00b87316ef79	Product name	1	20231116
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
05193eb6-d122-ab0b-603b-d9dd92599836	Product name	2	20210204
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
2e5437ef-ff80-c9c2-2f66-5b7c771080be	Product name	9	20180201
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
ae28a785-50d8-477d-a268-dffdfdd7504b	Product name	1	20150305
0c878822-66ca-456d-c17d-0894b04fa473	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-519-01	Heparin Sodium	1000 mL in 1 BAG	INJECTION, SOLUTION	1000	6
63323-519-02	Heparin Sodium	500 mL in 1 BAG	INJECTION, SOLUTION	500	6
63323-519-10	Heparin Sodium	12 in 1 CASE	INJECTION, SOLUTION	12	6
63323-519-77	Heparin Sodium	24 in 1 CASE	INJECTION, SOLUTION	24	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-519-01	ML - Milliliter	63323-519	b3a8687e-1a37-421c-b82a-71ecaaddd07f	1	2021-04-08
63323-519-02	ML - Milliliter	63323-519	139016e2-5fce-47e4-9f35-0883606bfd2e	1	2021-04-08
63323-519-10	ML - Milliliter	63323-519	c18dfa8a-520e-45d8-99aa-757e29f88ea4	1	2021-04-08
63323-519-77	ML - Milliliter	63323-519	db516ae3-738d-40f3-a20b-f395b1d2ce93	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-519	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC, 4 package rows	20240502_25b0ba06-3274-4a3f-8c39-42d13764ecdf.zip

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZZ45AB24CA	HEPARIN SODIUM	9041-08-1	HEPARIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1658692	heparin sodium, porcine 1000 UNT in 500 ML Injection	PSN	25b0ba06-3274-4a3f-8c39-42d13764ecdf	6
1658690	heparin sodium, porcine 2000 UNT in 1000 ML Injection	PSN	25b0ba06-3274-4a3f-8c39-42d13764ecdf	6
1658690	1000 ML heparin sodium, porcine 2 UNT/ML Injection	SCD	25b0ba06-3274-4a3f-8c39-42d13764ecdf	6
1658692	500 ML heparin sodium, porcine 2 UNT/ML Injection	SCD	25b0ba06-3274-4a3f-8c39-42d13764ecdf	6
1658692	heparin sodium, porcine 1000 UNT per 500 ML Injection	SY	25b0ba06-3274-4a3f-8c39-42d13764ecdf	6
1658690	heparin sodium, porcine 2000 UNT per 1000 ML Injection	SY	25b0ba06-3274-4a3f-8c39-42d13764ecdf	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-519-01	63323051901	1000 mL in 1 BAG	1000 ml					Historical
63323-519-02	63323051902	500 mL in 1 BAG	500 ml					Historical
63323-519-10	63323051910	12 BAG in 1 CASE (63323-519-10) / 1000 mL in 1 BAG (63323-519-01)	12 bag	2020-07-24	0000-00-00	No	No	Current
63323-519-77	63323051977	24 BAG in 1 CASE (63323-519-77) / 500 mL in 1 BAG (63323-519-02)	24 bag	2020-07-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Heparin Sodium	Fresenius Kabi USA, LLC \| HP Halden Pharma AS	2024-04-30	HUMAN PRESCRIPTION DRUG LABEL	6