Enoxaparin Sodium

Product NDC: 68001-636
Requested package NDC: 68001-636-42
11-digit product format: 680010636
Labeler code: 68001
Product ID: 68001-636_3ff02fbe-5a9d-e284-e063-6294a90a0ef8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enoxaparin Sodium
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: BluePoint Laboratories
Application: ANDA206834
Marketing category: ANDA
Marketing start: 2025-01-15
Substance: ENOXAPARIN SODIUM
Active strength: 100 mg/mL
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 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
A206834-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29
A206834-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29
A206834-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29
A206834-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29
A206834-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29
A206834-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29
A206834-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206834-001	AP
A206834-002	AP
A206834-003	AP
A206834-004	AP
A206834-005	AP
A206834-006	AP
A206834-007	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
2026-08-01 22:54:32	2026-06	A206834-001	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	30MG/0.3ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-002	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	40MG/0.4ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-003	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	60MG/0.6ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-004	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	80MG/0.8ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-005	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	100MG/ML (100MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-006	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	120MG/0.8ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-007	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	150MG/ML (150MG/ML)	INJECTABLE / SUBCUTANEOUS	AP	2019-11-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A206834-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-002	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-003	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-004	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-005	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-006	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206834-007	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enoxaparin Sodium	ENOXAPARIN SODIUM	Meitheal Pharmaceuticals Inc.	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206834 application number: ANDA206834
Enoxaparin Sodium	ENOXAPARIN SODIUM	Meitheal Pharmaceuticals Inc.	adbba7bb-fa72-4cec-aa69-13965591a45d	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206834 application number: ANDA206834
Enoxaparin Sodium	ENOXAPARIN SODIUM	BluePoint Laboratories	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206834 application number: ANDA206834 ndc (package): 68001-636-42 ndc (product): 68001-636 ndc11 (package): 68001063642
Enoxaparin Sodium	ENOXAPARIN SODIUM	NorthStar Rx LLC	32f8d292-0dda-4931-81ea-ba47e23edf61	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206834 application number: ANDA206834

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	100 mg/mL

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
a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	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
68001-636-42	Enoxaparin Sodium	10 in 1 CARTON	INJECTION	10		3
68001-636-43	Enoxaparin Sodium	0.8 mL in 1 SYRINGE	INJECTION	0.8		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-636-42	ML - Milliliter	68001-636	8500906d-1213-4633-86d8-cc1fbeaee93c	1	2025-01-14
68001-636-43	ML - Milliliter	68001-636	78efbf31-9161-4775-831e-cc6069dd1f9f	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-636	ENOXAPARIN SODIUM INJECTION [BLUEPOINT LABORATORIES]	2	Current NDC, 2 package rows	20250528_a2a8615b-a27e-4ab2-ae4c-592bbf4643c0.zip

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	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854245	enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe	PSN	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854252	enoxaparin sodium 150 MG in 1 ML Prefilled Syringe	PSN	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854245	0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854252	1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854245	0.8 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854252	1 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854252	enoxaparin 150 MG per 1 ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854245	enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	a2a8615b-a27e-4ab2-ae4c-592bbf4643c0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68001-636-42	68001063642	10 SYRINGE in 1 CARTON (68001-636-42) / .8 mL in 1 SYRINGE (68001-636-43)	10 syringe	2025-06-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enoxaparin Sodium	BluePoint Laboratories \| Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd.	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	3