Fludrocortisone Acetate (Page 3 of 3)

Salt-Losing Adrenogenital Syndrome

The recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of fludrocortisone acetate tablets daily.

HOW SUPPLIED

Fludrocortisone Acetate Tablets USP, 0.1 mg – Each white to off-white, round, convex tablet debossed with a “7033” on one side and with a bisect on the other side.
Unit dose packages of 50 (5 x 10) NDC 68084-288-65
Unit dose packages of 100 (10 x 10) NDC 68084-288-01

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals LLC as follows:
(0.1 mg / 50 UD) NDC 68084-288-65 packaged from NDC 0115-7033
(0.1 mg / 100 UD) NDC 68084-288-01 packaged from NDC 0115-7033

Distributed by:
American Health Packaging Columbus, OH 43217

8228801/1122F

Package/Label Display Panel — Carton — 0.1 mg – 100 UD

NDC 68084- 288 -01

Fludrocortisone
Acetate
Tablets, USP

0.1 mg

100 Tablets (10 x 10)                 Rx Only

Each Tablet Contains:
Fludrocortisone acetate …………………………………………………..0.1 mg

Usual Dosage: See package insert for full prescribing information.

Warning: Potent drug

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Avoid excess heat.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0115-7033, Amneal Pharmaceuticals LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

428801 0228801/0220

Package/Label Display Panel— Carton — 0.1 mg – 50 UD

NDC 68084- 288 -65

Fludrocortisone
Acetate
Tablets, USP

0.1 mg

50 Tablets (5 x 10)                 Rx Only

Each Tablet Contains:
Fludrocortisone acetate …………………………………………………..0.1 mg

Usual Dosage: See package insert for full prescribing information.

Warning: Potent drug

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Avoid excess heat.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0115-7033, Amneal Pharmaceuticals LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

028865 0228865/1122

Package/Label Display Panel — Blister — 0.1 mg

Fludrocortisone Acetate Tablet USP

0.1 mg

FLUDROCORTISONE ACETATE fludrocortisone acetate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-288(NDC:0115-7033) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUDROCORTISONE ACETATE (FLUDROCORTISONE) FLUDROCORTISONE ACETATE 0.1 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (CROSCARMELLOSE) LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE

Product Characteristics Color white (white to off-white) Score 2 pieces Shape ROUND (round, convex tablets) Size 6mm Flavor Imprint Code 7033 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68084-288-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-288-11) 1 NDC:68084-288-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-288-01) 2 NDC:68084-288-65 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68084-288-11) 2 NDC:68084-288-11 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68084-288-65)

(click image for full-size original)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040431 09/09/2008

Labeler — American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Operations
American Health Packaging		929561009	repack (68084-288)

Revised: 01/2023 American Health Packaging