ENOXAPARIN SODIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)

Available from:

Italfarmaco SpA

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENOXAPARIN SODIUM - ENOXAPARIN SODIUM INJECTION, SOLUTION
ITALFARMACO SPA
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ENOXAPARIN SODIUM INJECTION, FOR SUBCUTANEOUS AND INTRAVENOUS USE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 11797-757-06
Enoxaparin Sodium Injection USP
30 mg/0.3 mL
SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE
FOR SUBCUTANEOUS INJECTION
Ten 0.3 mL Syringes
NDC 11797-758-06
Enoxaparin Sodium Injection USP
40 mg/0.4 mL
SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE
FOR SUBCUTANEOUS INJECTION
Ten 0.4 mL Syringes
NDC 11797-759-06
Enoxaparin Sodium Injection USP
60 mg/0.6 mL
SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE
FOR SUBCUTANEOUS INJECTION
Ten 0.6 mL Syringes
NDC 11797-760-06
Enoxaparin Sodium Injection USP
80 mg/0.8 mL
SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE
FOR SUBCUTANEOUS INJECTION
Ten 0.8 mL Syringes
NDC 11797-761-06
ENOXAPARIN SODIUM INJECTION USP
100 MG/1 ML
SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE
FOR SUBCUTANEOUS INJECTION
TEN 1 mL Syringes
NDC 11797-762-06
Enoxaparin Sodium Injection USP
120 mg/0.8 mL
SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE
FOR SUBCUTANEOUS INJECTION
Ten 0.8 mL Syringes
NDC 11797-763-06
ENOXAPARIN SODIUM INJECTION USP
150 MG/1 ML
SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE
FOR SUBCUTANEOUS INJECTION
TEN 1 mL Syringes
ENOXAPARIN SODIUM
enoxaparin sodium injection, solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:11797-757
ROUTE OF ADMINISTRATION
INTRAVENOUS, SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN -
UNII:E47C0NF7LV)
ENOXAPARIN SODIUM
30 mg in 0.3 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:11797-
757-06
10 in 1 CARTON
04/01/2021
1
NDC:11797-
757-02
0.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGR