NDC Code(s) : 0009-0271-01
Packager : Pharmacia & Upjohn Company LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Depo-Estradiolestradiol cypionate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0271
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL CYPIONATE(UNII: 7E1DV054LO)
(ESTRADIOL - UNII:4TI98Z838E)
ESTRADIOL CYPIONATE5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
COTTONSEED OIL(UNII: H3E878020N)913 mg in 1 mL
CHLOROBUTANOL(UNII: HM4YQM8WRC)5.4 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-0271-011 in 1 CARTON 15/08/1979
15 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085470 08/15/1979

LABELER - Pharmacia & Upjohn Company LLC(618054084)

Establishment
Name Address ID/FEI Business Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS(0009-0271), API MANUFACTURE(0009-0271), LABEL(0009-0271), MANUFACTURE(0009-0271), PACK(0009-0271)

PRINCIPAL DISPLAY PANEL

5 mL Vial
NDC 0009-0271-01

Depo®-Estradiol
estradiol cypionate injection, USP

5 mg/mL

For intramuscular use only

Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0009-0271-01
Rx only

1–5 mL Vial

Depo®-Estradiol
estradiol cypionate
injection, USP

5 mg/mL

For intramuscular use only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 5 mg/mL Vial Carton