Enoxaparin Sodium

Product NDC: 71288-426
11-digit product format: 712880426
Labeler code: 71288
Product ID: 71288-426_72e0f228-ca47-4296-bd53-7e5ca00eb922
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enoxaparin Sodium
Dosage form: INJECTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA214856
Marketing category: ANDA
Marketing start: 2022-06-14
Substance: ENOXAPARIN SODIUM
Active strength: 300 mg/3mL
Pharmacologic classes: Heparin, Low-Molecular-Weight [CS], Low Molecular Weight 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 43.

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
A214856-001	ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB		2022-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214856-001	AB

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.

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	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214856-001	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	2022-06-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214856-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214856-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214856-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214856-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214856-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214856-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214856-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214856-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214856-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214856-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214856-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214856-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214856-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214856-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214856-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214856-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214856-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214856-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214856-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214856-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214856-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214856-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214856-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214856-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214856-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214856-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214856-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214856-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214856-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214856-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENOXAPARIN SODIUM	300 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8NZ41MIK1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854255	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
adfc2b23-00a5-4f05-a08b-83087e1e4843	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33a7d2c8-f5cf-4d97-8510-92190c5e0f12	Product name	7	20240606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71288-426-03	Enoxaparin Sodium	1 in 1 CARTON	INJECTION	1	6
71288-426-03	Enoxaparin Sodium	3 mL in 1 VIAL, MULTI-DOSE	INJECTION	3	6
71288-426-91	Enoxaparin Sodium	1 in 1 CARTON	INJECTION	1	1
71288-426-91	Enoxaparin Sodium	3 mL in 1 VIAL, MULTI-DOSE	INJECTION	3	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-426-03	ML - Milliliter	71288-426	06d9d397-37ae-474d-abe4-7577fb1eac9a	1	2022-09-12
71288-426-91	ML - Milliliter	71288-426	8affdfd2-a839-4a69-8535-03eb6add8c77	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-426	ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 2 package rows	20241208_7d38c307-767f-4c38-ac0e-b8bb62782602.zip
71288-426	ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]	1	Current NDC, Legacy NDC, 2 package rows	20240206_adfc2b23-00a5-4f05-a08b-83087e1e4843.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enoxaparin Sodium	ENOXAPARIN SODIUM	BluePoint Laboratories	d978e06e-b758-460b-81d3-69f7a5b89b00	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214856 application number: ANDA214856
Enoxaparin Sodium	ENOXAPARIN SODIUM	Meitheal Pharmaceuticals Inc.	7d38c307-767f-4c38-ac0e-b8bb62782602	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214856 application number: ANDA214856 ndc (product): 71288-426
Enoxaparin Sodium	ENOXAPARIN SODIUM	Meitheal Pharmaceuticals Inc.	adfc2b23-00a5-4f05-a08b-83087e1e4843	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214856 application number: ANDA214856 ndc (product): 71288-426

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8NZ41MIK1O	ENOXAPARIN SODIUM	679809-58-6	ENOXAPARIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854255	enoxaparin sodium 100 MG/ML Injectable Solution	PSN	7d38c307-767f-4c38-ac0e-b8bb62782602	6
854255	enoxaparin sodium 100 MG/ML Injectable Solution	SCD	7d38c307-767f-4c38-ac0e-b8bb62782602	6
854255	ENX sodium 100 MG/ML Injectable Solution	SY	7d38c307-767f-4c38-ac0e-b8bb62782602	6
854255	enoxaparin sodium 100 MG/ML Injectable Solution	PSN	adfc2b23-00a5-4f05-a08b-83087e1e4843	1
854255	enoxaparin sodium 100 MG/ML Injectable Solution	SCD	adfc2b23-00a5-4f05-a08b-83087e1e4843	1
854255	ENX sodium 100 MG/ML Injectable Solution	SY	adfc2b23-00a5-4f05-a08b-83087e1e4843	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-426-03	71288042603	1 VIAL, MULTI-DOSE in 1 CARTON (71288-426-03) / 3 mL in 1 VIAL, MULTI-DOSE	2022-06-14	0000-00-00	No	No	Current
71288-426-91	71288042691	1 VIAL, MULTI-DOSE in 1 CARTON (71288-426-91) / 3 mL in 1 VIAL, MULTI-DOSE	2022-06-14		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enoxaparin Sodium	Meitheal Pharmaceuticals Inc.	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	6
Enoxaparin Sodium	Meitheal Pharmaceuticals Inc. \| Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	2024-02-05	HUMAN PRESCRIPTION DRUG LABEL	1