Enoxaparin Sodium

Product NDC: 71288-435
11-digit product format: 712880435
Labeler code: 71288
Product ID: 71288-435_6f7ce651-e9dd-4c6b-a63c-1d911d63222a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enoxaparin Sodium
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA206834
Marketing category: ANDA
Marketing start: 2019-12-01
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: 2027-12-31
Current FDA listing: Yes

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	100 mg/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	8NZ41MIK1O
Rxcui	854228, 854235, 854238, 854241, 854245, 854248, 854252

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
71288-435-86	Enoxaparin Sodium	0.8 mL in 1 SYRINGE	INJECTION	0.8	4
71288-435-87	Enoxaparin Sodium	10 in 1 CARTON	INJECTION	10	4
71288-435-91	Enoxaparin Sodium	0.8 mL in 1 SYRINGE	INJECTION	0.8	3
71288-435-92	Enoxaparin Sodium	10 in 1 CARTON	INJECTION	10	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-435	ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 2 package rows	20230527_adbba7bb-fa72-4cec-aa69-13965591a45d.zip
71288-435	ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]	2	Current NDC, Legacy NDC, 2 package rows	20230527_b6fb85ab-1fe5-4dd3-a97f-adbed0674f67.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	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854245	enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe	PSN	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854252	enoxaparin sodium 150 MG in 1 ML Prefilled Syringe	PSN	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854245	0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854252	1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854245	0.8 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854252	1 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854252	enoxaparin 150 MG per 1 ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854245	enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	adbba7bb-fa72-4cec-aa69-13965591a45d	4
854248	enoxaparin sodium 100 MG in 1 ML Prefilled Syringe	PSN	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854245	enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe	PSN	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854252	enoxaparin sodium 150 MG in 1 ML Prefilled Syringe	PSN	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854245	0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854252	1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854245	0.8 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854252	1 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854252	enoxaparin 150 MG per 1 ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854245	enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	b6fb85ab-1fe5-4dd3-a97f-adbed0674f67	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-435-86	71288043586	0.8 mL in 1 SYRINGE	0.8 ml					Historical
71288-435-87	71288043587	10 SYRINGE in 1 CARTON (71288-435-87) / .8 mL in 1 SYRINGE (71288-435-86)	10 syringe	2019-12-01	0000-00-00	No	No	Current
71288-435-91	71288043591	0.8 mL in 1 SYRINGE	0.8 ml					Historical
71288-435-92	71288043592	10 SYRINGE in 1 CARTON (71288-435-92) / .8 mL in 1 SYRINGE (71288-435-91)	10 syringe	2019-12-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enoxaparin Sodium	Meitheal Pharmaceuticals Inc.	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	3
Enoxaparin Sodium	Meitheal Pharmaceuticals Inc.	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	4

Enoxaparin Sodium

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#