Enoxaparin Sodium

Product NDC: 63323-566
11-digit product format: 633230566
Labeler code: 63323
Product ID: 63323-566_2b6f0c59-240a-48ec-9cef-e55cc4b52274
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enoxaparin Sodium
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA078990
Marketing category: ANDA
Marketing start: 2019-04-23
Substance: ENOXAPARIN SODIUM
Active strength: 60 mg/.6mL
Pharmacologic classes: Heparin, Low-Molecular-Weight [CS], Low Molecular Weight 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 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078990-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28
A078990-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28
A078990-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28
A078990-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28
A078990-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28
A078990-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28
A078990-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A078990-001	AP
A078990-002	AP
A078990-003	AP
A078990-004	AP
A078990-005	AP
A078990-006	AP
A078990-007	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 8 · 287 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
2026-02-19 14:30 UTC	2026-02	A078990-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078990-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2018-09-28	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078990-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078990-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078990-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078990-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078990-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078990-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078990-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078990-005	AP	1	`03ed91905a0d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENOXAPARIN SODIUM	60 mg/.6mL

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854228	Internal RxNorm lookup
854235	Internal RxNorm lookup
854238	Internal RxNorm lookup
854241	Internal RxNorm lookup
854248	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
c3be543e-8aff-4311-bf77-e7a5a814ca6f	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
63323-566-21	Enoxaparin Sodium	1 in 1 BLISTER PACK	INJECTION	1	9
63323-566-21	Enoxaparin Sodium	0.6 mL in 1 SYRINGE	INJECTION	0.6	9
63323-566-98	Enoxaparin Sodium	10 in 1 CARTON	INJECTION	10	9
63323-566-63	Enoxaparin Sodium	0.6 mL in 1 SYRINGE	INJECTION	0.6	3
63323-566-63	Enoxaparin Sodium	1 in 1 BLISTER PACK	INJECTION	1	3
63323-566-65	Enoxaparin Sodium	10 in 1 CARTON	INJECTION	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-566-21	ML - Milliliter	63323-566	b0671436-5754-4519-86bc-2fd9c9b98043	1	2019-11-12
63323-566-63	ML - Milliliter	63323-566	36fa0f99-3d79-49cd-ad66-76471f6ed335	1	2023-02-06
63323-566-65	ML - Milliliter	63323-566	1ee4c02d-8d4b-44fa-8862-d15cac2c1dcc	1	2023-02-06
63323-566-98	ML - Milliliter	63323-566	ceb17263-3e9c-42ac-b7fe-f0acf4f998d7	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-566	ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]	8	Current NDC, Legacy NDC, 3 package rows	20240731_a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e.zip
63323-566	ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]	2	Current NDC, Legacy NDC, 3 package rows	20230623_c3be543e-8aff-4311-bf77-e7a5a814ca6f.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enoxaparin Sodium	ENOXAPARIN SODIUM	Cardinal Health 107, LLC	45a66675-b159-42b8-9f18-ff80f28e1503	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078990 application number: ANDA078990
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	c3be543e-8aff-4311-bf77-e7a5a814ca6f	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078990 application number: ANDA078990 ndc (product): 63323-566
ENOXAPARIN SODIUM	ENOXAPARIN SODIUM	Gland Pharma Limited	65025e0d-eb54-4c4e-bd14-f294ce038902	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078990 application number: ANDA078990
Enoxaparin Sodium	ENOXAPARIN SODIUM	Civica, Inc.	b4728749-8453-4f07-9fbc-a1f3e9d2708b	2025-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078990 application number: ANDA078990
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078990 application number: ANDA078990 ndc (product): 63323-566
Enoxaparin Sodium	ENOXAPARIN SODIUM	Sagent Pharmaceuticals	419a3566-4f67-4c8d-86e5-c00c7ec429e1	2023-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078990 application number: ANDA078990

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
854248	enoxaparin sodium 100 MG in 1 ML Prefilled Syringe	PSN	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854245	enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe	PSN	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854252	enoxaparin sodium 150 MG in 1 ML Prefilled Syringe	PSN	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854245	0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854252	1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854245	0.8 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854252	1 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854252	enoxaparin 150 MG per 1 ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854245	enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e	9
854248	enoxaparin sodium 100 MG in 1 ML Prefilled Syringe	PSN	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	c3be543e-8aff-4311-bf77-e7a5a814ca6f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-566-21	63323056621	1 in 1 BLISTER PACK						Historical
63323-566-63	63323056663	0.6 mL in 1 SYRINGE	0.6 ml					Historical
63323-566-65	63323056665	10 BLISTER PACK in 1 CARTON (63323-566-65) / 1 SYRINGE in 1 BLISTER PACK (63323-566-63) / .6 mL in 1 SYRINGE	10 blister pack	2019-04-23	0000-00-00	No	No	Current
63323-566-98	63323056698	10 BLISTER PACK in 1 CARTON (63323-566-98) / 1 SYRINGE in 1 BLISTER PACK (63323-566-21) / .6 mL in 1 SYRINGE	10 blister pack	2019-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enoxaparin Sodium	Fresenius Kabi USA, LLC \| Gland Pharma Limited	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	3
Enoxaparin Sodium	Fresenius Kabi USA, LLC \| Gland Pharma Limited	2025-03-19	HUMAN PRESCRIPTION DRUG LABEL	9