NDC Code(s) : 65862-934-87, 65862-934-88, 65862-934-58
Packager : Aurobindo Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aurovela 24 FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-934
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
RAW SUGAR(UNII: 8M707QY5GH)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SPEARMINT OIL(UNII: C3M81465G5)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SUCRALOSE(UNII: 96K6UQ3ZD4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-934-871 in 1 CARTON 15/06/2017
11 in 1 POUCH
11 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:65862-934-883 in 1 CARTON 15/06/2017
21 in 1 POUCH
21 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:65862-934-585 in 1 CARTON 15/06/2017
31 in 1 POUCH
31 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207504 06/15/2017

LABELER - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 650381903 ANALYSIS(65862-934), MANUFACTURE(65862-934)

PRINCIPAL DISPLAY PANEL

NDC 65862-934-87
28 Day Regimen

Aurovela® 24 Fe provides
24 days of active therapy

Aurovela® 24 Fe
(Norethindrone Acetate and Ethinyl Estradiol
Tablets USP and Ferrous Fumarate Tablets)
1 mg/20 mcg

Each light yellow to yellow tablet contains norethindrone
acetate USP, 1 mg: ethinyl estradiol USP, 20 mcg; each brown
tablet contains ferrous fumarate USP, 75 mg.

Each pouch contains 24 light yellow to yellow tablets and 4
brown tablets.

This product (like all oral contraceptives) is
intended to prevent pregnancy. It does not
protect against HIV infection (AIDS) and other
sexually transmitted diseases.

Rx only                                     This pouch contains 
                                                one blister card  of 28 tablets

AUROBINDO    



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/20 mcg Pouch Label

PRINCIPAL DISPLAY PANEL

NDC 65862-934-58
 28 Day Regimen

Aurovela® 24 Fe provides
 24 days of active therapy

Aurovela® 24 Fe
 (Norethindrone Acetate and Ethinyl Estradiol
Tablets USP  and Ferrous Fumarate Tablets )
1 mg/20 mcg

 This product (like all oral contraceptives) is intended to prevent pregnancy. It does not
protect against HIV infection (AIDS) and other sexually transmitted diseases.

                                                 This carton contains 5 pouches.
Rx only              Each pouch contains 1 blister card of 28 tablets.

AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/20 mcg Pouch Carton Label