Estradiol Valerate (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 0143-9289 -01 Rx only
Estradiol Valerate
Injection, USP
50 mg per 5 mL
(10 mg/mL)
For Intramuscular use ONLY
5 mL Multiple Dose Vial STERILE

50 mg vial
(click image for full-size original)

NDC 0143-9289 -01 Rx only
5 mL Multiple Dose Vial
Estradiol Valerate
Injection, USP
50 mg per 5 mL
(10 mg/mL)
STERILEFor Intramuscular use ONLY

50 mg carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9290 -01 Rx only
Estradiol Valerate
Injection, USP
100 mg per 5 mL
(20 mg/mL)
For Intramuscular use ONLY
5 mL Multiple Dose Vial STERILE

100 mg vial
(click image for full-size original)

NDC 0143-9290 -01 Rx only
5 mL Multiple Dose Vial
Estradiol Valerate
Injection, USP
100 mg per 5 mL
(20 mg/mL)
STERILEFor Intramuscular use ONLY

100 mg carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9291 -01 Rx only
Estradiol Valerate
Injection, USP
200 mg per 5 mL
(40 mg/mL)
For Intramuscular use ONLY5 mL Multiple Dose Vial STERILE

200 mg vial
(click image for full-size original)

NDC 0143-9291 -01 Rx only
5 mL Multiple Dose Vial
Estradiol Valerate
Injection, USP
200 mg per 5 mL
(40 mg/mL)
STERILEFor Intramuscular use ONLY

200 mg carton
(click image for full-size original)

SERIALIZATION IMAGE

Layout 1
(click image for full-size original)
ESTRADIOL VALERATE estradiol valerate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9290
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL VALERATE (ESTRADIOL) ESTRADIOL VALERATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE
BENZYL ALCOHOL
CASTOR OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9290-01 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (0143-9290-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203723 04/21/2020
ESTRADIOL VALERATE estradiol valerate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9291
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL VALERATE (ESTRADIOL) ESTRADIOL VALERATE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE
BENZYL ALCOHOL
CASTOR OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9291-01 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (0143-9291-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203723 04/21/2020
ESTRADIOL VALERATE estradiol valerate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9289
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL VALERATE (ESTRADIOL) ESTRADIOL VALERATE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL
SESAME OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9289-01 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (0143-9289-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203723 04/21/2020
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 07/2022 Hikma Pharmaceuticals USA Inc.

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