Enoxaparin Sodium

Product NDC: 63323-533
11-digit product format: 633230533
Labeler code: 63323
Product ID: 63323-533_53e20cb1-9e79-4c45-a5a7-62c3904df818
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: enoxaparin sodium
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA020164
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-06-18
Substance: ENOXAPARIN SODIUM
Active strength: 30 mg/.3mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020164-001	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29
N020164-002	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30
N020164-003	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27
N020164-004	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27
N020164-005	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27
N020164-006	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02
N020164-007	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02
N020164-008	LOVENOX (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02
N020164-009	LOVENOX	ENOXAPARIN SODIUM	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N020164-001	AP
N020164-002	AP
N020164-003	AP
N020164-004	AP
N020164-005	AP
N020164-007	AP
N020164-008	AP
N020164-009	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.

Product history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-005	LOVENOX (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-006	LOVENOX (PRESERVATIVE FREE)	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-007	LOVENOX (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-008	LOVENOX (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-009	LOVENOX	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-005	LOVENOX (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-006	LOVENOX (PRESERVATIVE FREE)	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-007	LOVENOX (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-008	LOVENOX (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-009	LOVENOX	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-005	LOVENOX (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-006	LOVENOX (PRESERVATIVE FREE)	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-007	LOVENOX (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-008	LOVENOX (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-009	LOVENOX	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-005	LOVENOX (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-006	LOVENOX (PRESERVATIVE FREE)	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	2000-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-007	LOVENOX (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-008	LOVENOX (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	2000-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-009	LOVENOX	300MG/3ML (100MG/ML)	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AB	RLD	2003-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-001	LOVENOX (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1993-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-002	LOVENOX (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-003	LOVENOX (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-004	LOVENOX (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD	1998-03-27	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 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	N020164-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020164-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020164-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020164-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020164-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020164-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020164-009	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-008	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020164-009	AB	1	`fd3edfee7708…`

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	30 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 · 8 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
854245	Internal RxNorm lookup
854248	Internal RxNorm lookup
854252	Internal RxNorm lookup
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
21b095d1-5ade-43e9-9114-30fbfb2331c9	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-533-01	Enoxaparin Sodium	1 in 1 CELLO PACK	INJECTION	1	9
63323-533-01	Enoxaparin Sodium	0.3 mL in 1 SYRINGE	INJECTION	0.3	9
63323-533-83	Enoxaparin Sodium	10 in 1 CARTON	INJECTION	10	9
63323-533-13	Enoxaparin Sodium	1 in 1 CELLO PACK	INJECTION	1	7
63323-533-13	Enoxaparin Sodium	0.3 mL in 1 SYRINGE	INJECTION	0.3	7
63323-533-93	Enoxaparin Sodium	10 in 1 CARTON	INJECTION	10	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-533-01	ML - Milliliter	63323-533	00f2f41f-b1a1-4e03-9c62-df5cbb1b4f11	1	2020-02-13
63323-533-13	ML - Milliliter	63323-533	997c26b2-ab4b-4694-866c-7e3063c31b80	1	2019-12-10
63323-533-83	ML - Milliliter	63323-533	8b563838-62cc-4fa5-97dc-4d05f29061c5	1	2020-02-13
63323-533-93	ML - Milliliter	63323-533	df02c956-0917-4911-8b50-3bc212ae4b0b	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-533	ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20230105_21b095d1-5ade-43e9-9114-30fbfb2331c9.zip
63323-533	ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 3 package rows	20220125_066f27ec-352c-4051-ba29-248e292690db.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
Lovenox	ENOXAPARIN SODIUM	Sanofi-Aventis U.S. LLC	5017a927-2a24-4f27-89f9-27c805bf7d59	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164
Lovenox	ENOXAPARIN SODIUM	Cardinal Health 107, LLC	3d263380-4f44-4fd8-aa2a-e69702ab258f	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164
Lovenox	ENOXAPARIN SODIUM	Sanofi-Aventis U.S. LLC	de6fb917-a94a-41ea-9d7d-937d4080ffcd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164
Enoxaparin sodium	ENOXAPARIN SODIUM	Sanofi-Aventis U.S. LLC	20635579-c92d-4f6c-a332-1096d51002f2	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	21b095d1-5ade-43e9-9114-30fbfb2331c9	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164 ndc (product): 63323-533
Enoxaparin Sodium	ENOXAPARIN SODIUM	Fresenius Kabi USA, LLC	066f27ec-352c-4051-ba29-248e292690db	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020164 application number: NDA020164 ndc (product): 63323-533

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	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854255	enoxaparin sodium 100 MG/ML Injectable Solution	PSN	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854245	enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe	PSN	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854252	enoxaparin sodium 150 MG in 1 ML Prefilled Syringe	PSN	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854245	0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854252	1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854255	enoxaparin sodium 100 MG/ML Injectable Solution	SCD	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854245	0.8 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854252	1 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854252	enoxaparin 150 MG per 1 ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854245	enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854255	ENX sodium 100 MG/ML Injectable Solution	SY	21b095d1-5ade-43e9-9114-30fbfb2331c9	9
854248	enoxaparin sodium 100 MG in 1 ML Prefilled Syringe	PSN	066f27ec-352c-4051-ba29-248e292690db	7
854255	enoxaparin sodium 100 MG/ML Injectable Solution	PSN	066f27ec-352c-4051-ba29-248e292690db	7
854245	enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe	PSN	066f27ec-352c-4051-ba29-248e292690db	7
854252	enoxaparin sodium 150 MG in 1 ML Prefilled Syringe	PSN	066f27ec-352c-4051-ba29-248e292690db	7
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	066f27ec-352c-4051-ba29-248e292690db	7
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	066f27ec-352c-4051-ba29-248e292690db	7
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	066f27ec-352c-4051-ba29-248e292690db	7
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	066f27ec-352c-4051-ba29-248e292690db	7
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	066f27ec-352c-4051-ba29-248e292690db	7
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	066f27ec-352c-4051-ba29-248e292690db	7
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	066f27ec-352c-4051-ba29-248e292690db	7
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	066f27ec-352c-4051-ba29-248e292690db	7
854245	0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	066f27ec-352c-4051-ba29-248e292690db	7
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	066f27ec-352c-4051-ba29-248e292690db	7
854252	1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	066f27ec-352c-4051-ba29-248e292690db	7
854255	enoxaparin sodium 100 MG/ML Injectable Solution	SCD	066f27ec-352c-4051-ba29-248e292690db	7
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854245	0.8 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854252	1 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854252	enoxaparin 150 MG per 1 ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854245	enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	066f27ec-352c-4051-ba29-248e292690db	7
854255	ENX sodium 100 MG/ML Injectable Solution	SY	066f27ec-352c-4051-ba29-248e292690db	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-533-01	63323053301	1 in 1 CELLO PACK						Historical
63323-533-13	63323053313	1 in 1 CELLO PACK						Historical
63323-533-83	63323053383	10 CELLO PACK in 1 CARTON (63323-533-83) / 1 SYRINGE in 1 CELLO PACK (63323-533-01) / .3 mL in 1 SYRINGE	10 cello pack	2019-06-18	0000-00-00	No	No	Current
63323-533-93	63323053393	10 CELLO PACK in 1 CARTON (63323-533-93) / 1 SYRINGE in 1 CELLO PACK (63323-533-13) / .3 mL in 1 SYRINGE	10 cello pack	2019-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enoxaparin Sodium	Fresenius Kabi USA, LLC \| Sanofi-Aventis Singapore Pte. Ltd. \| Sanofi Winthrop Industrie \| Sanofi-Aventis Deutschland GmbH \| Patheon Manufacturing Services LLC	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	9
Enoxaparin Sodium	Fresenius Kabi USA, LLC \| Sanofi-Aventis Singapore Pte. Ltd. \| Sanofi Winthrop Industrie \| Sanofi-Aventis Deutschland GmbH \| Patheon Manufacturing Services LLC	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	7