NDC Code(s) : 0051-4390-13
Packager : AbbVie Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clorazepate Dipotassium Clorazepate Dipotassium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0051-4390
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLORAZEPATE DIPOTASSIUM(UNII: 63FN7G03XY)
(CLORAZEPIC ACID - UNII:D51WO0G0L4) 		CLORAZEPATE DIPOTASSIUM7.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POTASSIUM CARBONATE(UNII: BQN1B9B9HA)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color ORANGE (ORANGE) Score 2 pieces
Shape FREEFORM (FREEFORM) Size 9 mm
Flavor Imprint Code T;OV;32
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0051-4390-13100 in 1 BOTTLE Type 0: Not a Combination Product23/06/1972
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA017105 06/23/1972 04/30/2018

PRINCIPAL DISPLAY PANEL

NDC 55292-302-01


100 Tablets

Tranxene* T-Tab® Tablets
(clorazepate dipotassium tablets, USP)

7.5 mg CIV

DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT. GO TO www.recordatirarediseases.com

Rx only 

RECORDATI RARE DISEASES GROUP

Each tablet contains 7.5 mg clorazepate dipotassium.

See package insert for full prescribing information.

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

Protect from moisture. Keep bottle tightly closed.

Dispense in a USP tight, light-resistant container.

Do not accept if seal over bottle opening is broken or missing.

Manufactured by:
AbbVie LTD
Barceloneta, PR 00617

For: Recordati Rare Diseases Inc.
Lebanon, NJ 08833, U.S.A.

Exp.

Lot


04-B186-R6 (4390)

7.5 mg