NDC Code(s) : 42291-672-90, 42291-672-01, 42291-672-50
Packager : AvKARE, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-672(NDC:62037-999)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
(POTASSIUM CATION - UNII:295O53K152) 		POTASSIUM CATION20 meq
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
DIETHYL PHTHALATE(UNII: UF064M00AF)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Crospovidone (15 Mpa.s At 5%)(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL (Capsule shaped) Size 21 mm
Flavor Imprint Code ABRS;123
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-672-9090 in 1 BOTTLE Type 0: Not a Combination Product07/05/2014
2NDC:42291-672-01100 in 1 BOTTLE Type 0: Not a Combination Product07/05/2014
3NDC:42291-672-50500 in 1 BOTTLE Type 0: Not a Combination Product07/05/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076368 05/07/2014 05/01/2017

PRINCIPAL DISPLAY PANEL

AvKARE
NDC 42291-672-01

Potassium Chloride Extended-release Tablets USP
1500 mg (20 mEq K)

100 Tablets        Rx Only

Each tablet contains:
Potassium Chloride, 1500 mg equivalent to 20 mEq of Potassium.

Usual dose: See accompanying package outsert.

Dispense in a tight, light-resistant container as defined in USP/NF.

Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP.]

Keep tightly closed.

Keep this and all drugs out of the reach of children.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 7681 (03/08)         AV 04/14 (P)

N3   42291 67201   7