EPOPROSTENOL injection, powder, lyophilized, for solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

EPOPROSTENOL SODIUM (UNII: 4K04IQ1OF4) (EPOPROSTENOL - UNII:DCR9Z582X0)

Sẵn có từ:

Sun Pharmaceutical Industries, Inc.

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Export only

Đặc tính sản phẩm

EPOPROSTENOL - EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
EPOPROSTENOL FOR INJECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.5 MG-LABEL
UNAPPROVED
NDC 62756-175-40
EPOPROSTENOL FOR INJECTION
0.5 MG (500,000 NG)/VIAL
For Intravenous Infusion Only
Sterile, Lyophilized Product
10 mL Single-dose Vial
Discard Unused Portion
RX ONLY
SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.5 NG CARTON
UNAPPROVED
NDC 62756-175-40
EPOPROSTENOL FOR INJECTION
0.5 MG (500,000 NG)/VIAL
For Intravenous Infusion Only
Sterile, Lyophilized Product
1 x 10 mL Single-dose Vial
Discard Unused Portion
RX ONLY
SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1.5 NG LABEL
UNAPPROVED
NDC 62756-176-40
EPOPROSTENOL FOR INJECTION
1.5 MG (1,500,000 NG)/VIAL
For Intravenous Infusion Only
Sterile, Lyophilized Product
10 mL Single-dose Vial
Discard Unused Portion
RX ONLY
SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1.5 NG CARTON
UNAPPROVED
NDC 62756-176-40
EPOPROSTENOL FOR INJECTION
1.5 MG (1,500,000 NG)/VIAL
For Intravenous Infusion Only
Sterile, Lyophilized Product
1 x 10 mL Single-dose Vial
Discard Unused Portion
RX ONLY
SUN PHARMA
EPOPROSTENOL
epoprostenol injection, powder, lyophilized, for solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 2756 -175
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
EPO PRO STENO L SO DIUM (UNII: 4K0 4IQ1OF4) (EPOPROSTENOL - UNII:DCR9
Z58 2X0 )
EPOPROSTENOL
0 .5 mg in 10 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SUCRO SE (UNII: C151H8 M554)
GLYCINE (UNII: TE76 6 0 XO1C)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 2756 -175-40
1 in 1 CARTON
11/0 1/20 20
1
10 mL in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
EXPORT O