Prescription Drug Information: Phenobarbital (Page 3 of 3)

HOW SUPPLIED

Phenobarbital Tablets, USP 32.4 mg: White, round, tablets scored on one side and debossed “e5″ above the score and “111” below the score. The other side is plain. Available in bottles of 30 tablets, NDC 43063-953-30.

Storage and Handling

Store at 20°- 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

PRINCIPAL DISPLAY PANEL

Phenobarbital Tablets, USP 32.4 mg container label

43063953 label
(click image for full-size original)
PHENOBARBITAL
phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-953(NDC:13517-111)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 32.4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code e5;111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-953-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/24/2017 11/09/2025
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-953)

Revised: 09/2023 PD-Rx Pharmaceuticals, Inc.

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