enoxaparin sodium

Product NDC: 28955-101
11-digit product format: 289550101
Labeler code: 28955
Product ID: 28955-101_486592e2-4eef-525e-e063-6394a90a3048
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: enoxaparin sodium
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Hebei Changshan Biochemical Pharmaceutical Co., Ltd.
Application: ANDA218775
Marketing category: ANDA
Marketing start: 2026-05-01
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 43.

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
A218775-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07
A218775-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07
A218775-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07
A218775-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07
A218775-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07
A218775-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07
A218775-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218775-001	AP
A218775-002	AP
A218775-003	AP
A218775-004	AP
A218775-005	AP
A218775-006	AP
A218775-007	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.

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	A218775-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218775-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218775-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2026-01-07	`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	A218775-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-006	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218775-007	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218775-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218775-007	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218775-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218775-007	AP	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-004	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-005	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-006	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218775-007	AP	1	`a50c72e98297…`

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: 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 · 7 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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
7fa78f8d-92d9-434a-8e26-b886ab0ae77f	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	Strength	SPL version
28955-101-10	enoxaparin sodium	10 in 1 CARTON	INJECTION	10		2
28955-101-10	enoxaparin sodium	0.3 mL in 1 SYRINGE	INJECTION	0.3		2

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
enoxaparin sodium	ENOXAPARIN SODIUM	Hebei Changshan Biochemical Pharmaceutical Co., Ltd.	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218775 application number: ANDA218775 ndc (product): 28955-101

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	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854245	enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe	PSN	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854252	enoxaparin sodium 150 MG in 1 ML Prefilled Syringe	PSN	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854245	0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854252	1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854245	0.8 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854252	1 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854252	enoxaparin 150 MG per 1 ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854245	enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	7fa78f8d-92d9-434a-8e26-b886ab0ae77f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
28955-101-10	28955010110	10 SYRINGE in 1 CARTON (28955-101-10) / .3 mL in 1 SYRINGE	10 syringe	2026-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
enoxaparin sodium	Hebei Changshan Biochemical Pharmaceutical Co., Ltd.	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	2