Ethambutol Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Ethambutol Hydrochloride Tablets USP, 400 mg are available as white to off-white, round, biconvex, film-coated tablets debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘C32’ on other side.

They are supplied as follows:

NDC: 70518-2966-00

NDC: 70518-2966-01

NDC: 70518-2966-02

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

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

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Ethambutol Hydrochloride

GENERIC: Ethambutol Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2966-0

NDC: 70518-2966-1

NDC: 70518-2966-2

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 12 mm

IMPRINT: L;U;C32

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • ETHAMBUTOL HYDROCHLORIDE 400mg in 1

INACTIVE INGREDIENT(S):

  • ETHYLCELLULOSES
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 4000
  • POVIDONE
  • PROPYLENE GLYCOL
  • SILICON DIOXIDE
  • STARCH, CORN
  • TALC
  • TITANIUM DIOXIDE
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
MM3
(click image for full-size original)
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2966(NDC:68180-281)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL) ETHAMBUTOL HYDROCHLORIDE 400 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSES
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POVIDONE
PROPYLENE GLYCOL
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND (Biconvex) Size 12mm
Flavor Imprint Code L;U;C32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2966-0 30 TABLET in 1 BLISTER PACK None
2 NDC:70518-2966-1 100 POUCH in 1 BOX contains a POUCH (70518-2966-2)
2 NDC:70518-2966-2 1 TABLET in 1 POUCH This package is contained within the BOX (70518-2966-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078939 12/11/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 09/2023 REMEDYREPACK INC.

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