Heparin Sodium

Product NDC: 68083-428
11-digit product format: 680830428
Labeler code: 68083
Product ID: 68083-428_7b0f85d1-774a-4644-af2f-c798d9c202a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Heparin Sodium
Dosage form: INJECTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Gland Pharma Limited
Application: ANDA205323
Marketing category: ANDA
Marketing start: 2019-11-18
Substance: HEPARIN SODIUM
Active strength: 1000 [USP'U]/mL
Pharmacologic classes: Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A205323-001	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP		2017-02-06
A205323-002	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP		2019-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205323-001	AP
A205323-002	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 3 · 82 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
2026-09-14 22:38:34	2026-08	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205323-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205323-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-02-06	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A205323-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205323-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205323-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205323-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205323-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205323-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205323-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205323-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205323-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205323-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205323-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205323-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205323-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205323-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205323-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205323-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205323-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205323-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205323-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205323-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205323-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205323-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205323-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205323-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205323-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205323-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205323-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205323-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205323-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205323-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205323-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205323-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205323-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205323-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205323-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A205323-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205323-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A205323-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205323-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205323-002	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Heparin Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HEPARIN SODIUM	1000 [USP'U]/mL

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
05193eb6-d122-ab0b-603b-d9dd92599836	Product name	2	20210204
2e5437ef-ff80-c9c2-2f66-5b7c771080be	Product name	9	20180201
ae28a785-50d8-477d-a268-dffdfdd7504b	Product name	1	20150305
0c878822-66ca-456d-c17d-0894b04fa473	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68083-428-25	2024-01-30	C162847	48780-1	1030e365-00c1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION. HEPARIN SODIUM injection, for intravenous or subcutaneous use Initial U.S. Approval: 1939
68083-428-25	2024-01-30	C162847	48780-1	1030e365-00c1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION. HEPARIN SODIUM injection, for intravenous or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-428-01	Heparin Sodium	30 mL in 1 VIAL, MULTI-DOSE	INJECTION	30		12
68083-428-25	Heparin Sodium	25 in 1 CARTON	INJECTION	25		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-428	HEPARIN SODIUM INJECTION [GLAND PHARMA LIMITED]	12	Current NDC, 2 package rows	20241119_301b19bc-21c2-4a35-9d29-569b08d855c4.zip

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
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	301b19bc-21c2-4a35-9d29-569b08d855c4	12
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	PSN	301b19bc-21c2-4a35-9d29-569b08d855c4	12
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	301b19bc-21c2-4a35-9d29-569b08d855c4	12
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	SCD	301b19bc-21c2-4a35-9d29-569b08d855c4	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68083-428-01	68083042801	30 mL in 1 VIAL, MULTI-DOSE	30 ml				Historical
68083-428-25	68083042825	25 VIAL, MULTI-DOSE in 1 CARTON (68083-428-25) / 30 mL in 1 VIAL, MULTI-DOSE (68083-428-01)		2019-11-18	No	No	Current