NDC Code(s) : 75854-602-28, 75854-602-02, 75854-602-03
Packager : Avion Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Balcoltralevonorgestrel and ethinyl estradiol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-602
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C RED NO. 40(UNII: WZB9127XOA)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
FERROUS BISGLYCINATE(UNII: SFW1D987QV)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GLYCINE(UNII: TE7660XO1C)
WATER(UNII: 059QF0KO0R)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75854-602-281 in 1 CARTON 04/10/2018
11 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:75854-602-022 in 1 CARTON 04/10/2018
21 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:75854-602-033 in 1 CARTON 04/10/2018
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
NDA NDA208612 04/10/2018

LABELER - Avion Pharmaceuticals(040348516)

REGISTRANT - Avion Pharmaceuticals(040348516)

Establishment
Name Address ID/FEI Business Operations
Novast Laboratories, Ltd. 527695995 analysis(75854-602), label(75854-602), manufacture(75854-602), pack(75854-602)

PRINCIPAL DISPLAY PANEL

image description

 Blister Pack,
28 tablets.

NDC 75854-602-28
28-day regimen

Balcoltra®(levonorgestrel and ethinyl estradiol tablets, USP,  and ferrous bisglycinate tablets) 0.1mg/0.02mg and 36.5mg

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

Rx Only

The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.

Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.

1 Blister Pack, 28 tablets

Balcoltra® (Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets)

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke.

NDC 75854-602-28
28-day regimen

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton Back

1 Blister Pack,

28 tablets

NDC 75854-602-28
28-day regimen

Balcoltra ® Levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) 0.1mg/0.02mg and 36.5mg.

IMPORTANT: Note to Dispensing Pharmacist: Each compact dispenser contains a combination Patient Information and Instructions For Use Insert with Day Label Stickers. This should be included with each package dispensed to the patient.

Each active orange tablet (21) contains levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg.
Each inactive blue tablet (7) contains ferrous bisglycinate 36.5 mg.

Contains color additives including FD&C Yellow No. 5 (tartrazine).

Usual Dosage: One orange tablet daily for 21 consecutive days followed by one blue placebo tablet for 7 consecutive days according to prescribed schedule.

See enclosed prescribing information.

Store at 20° to 25°C (68° to 77°F); Excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature.]Protect from light.

Keep out of the reach of children.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children.
In case of accidental overdose, call a doctor or poison control center immediately.

Avion

Pharmaceuticals

Manufactured for:
Avion Pharmaceuticals, LLC., Alpharetta, GA 30005
1-888-61-AVION

Manufactured by:
Novast Laboratories, Ltd., Nantong, China 226009

Rx Only

Iss. 04/2022 Rev C
C0154