Enoxaparin Sodium

Product NDC: 68001-458
11-digit product format: 680010458
Labeler code: 68001
Product ID: 68001-458_018c897c-b446-14d9-e063-6294a90a35ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Enoxaparin sodium
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: BluePoint Laboratories
Application: ANDA076684
Marketing category: ANDA
Marketing start: 2020-10-19
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

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 Identifiers#

Field, Values table
Field	Values
Unii	8NZ41MIK1O
Rxcui	854228, 854235, 854238, 854241, 854245, 854248, 854252, 854255

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
68001-458-42	Enoxaparin Sodium	10 in 1 CARTON	INJECTION	10		7
68001-458-43	Enoxaparin Sodium	0.4 mL in 1 SYRINGE	INJECTION	0.4		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-458	ENOXAPARIN SODIUM INJECTION ENOXAPARIN SODIUM INJECTION [BLUEPOINT LABORATORIES]	7	Current NDC, Legacy NDC, 2 package rows	20230801_9e2875df-0f0c-46ec-990f-69108f383f58.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	9e2875df-0f0c-46ec-990f-69108f383f58	7
854255	enoxaparin sodium 100 MG/ML Injectable Solution	PSN	9e2875df-0f0c-46ec-990f-69108f383f58	7
854245	enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe	PSN	9e2875df-0f0c-46ec-990f-69108f383f58	7
854252	enoxaparin sodium 150 MG in 1 ML Prefilled Syringe	PSN	9e2875df-0f0c-46ec-990f-69108f383f58	7
854228	enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe	PSN	9e2875df-0f0c-46ec-990f-69108f383f58	7
854235	enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe	PSN	9e2875df-0f0c-46ec-990f-69108f383f58	7
854238	enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe	PSN	9e2875df-0f0c-46ec-990f-69108f383f58	7
854241	enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe	PSN	9e2875df-0f0c-46ec-990f-69108f383f58	7
854228	0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	9e2875df-0f0c-46ec-990f-69108f383f58	7
854235	0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	9e2875df-0f0c-46ec-990f-69108f383f58	7
854238	0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	9e2875df-0f0c-46ec-990f-69108f383f58	7
854241	0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	9e2875df-0f0c-46ec-990f-69108f383f58	7
854245	0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	9e2875df-0f0c-46ec-990f-69108f383f58	7
854248	1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe	SCD	9e2875df-0f0c-46ec-990f-69108f383f58	7
854252	1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe	SCD	9e2875df-0f0c-46ec-990f-69108f383f58	7
854255	enoxaparin sodium 100 MG/ML Injectable Solution	SCD	9e2875df-0f0c-46ec-990f-69108f383f58	7
854228	0.3 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854235	0.4 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854238	0.6 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854241	0.8 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854245	0.8 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854248	1 ML ENX sodium 100 MG/ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854252	1 ML ENX sodium 150 MG/ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854252	enoxaparin 150 MG per 1 ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854248	enoxaparin sodium 100 MG per 1 ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854245	enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854228	enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854235	enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854238	enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854241	enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7
854255	ENX sodium 100 MG/ML Injectable Solution	SY	9e2875df-0f0c-46ec-990f-69108f383f58	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-458-42	68001045842	10 SYRINGE in 1 CARTON (68001-458-42) / .4 mL in 1 SYRINGE (68001-458-43)	10 syringe	2020-10-19	0000-00-00	No	No	Current
68001-458-43	68001045843	0.4 mL in 1 SYRINGE	0.4 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enoxaparin Sodium	BluePoint Laboratories \| Amphastar Pharmaceuticals, Inc.	2023-07-28	HUMAN PRESCRIPTION DRUG LABEL	7

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#