Ethambutol Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Ethambutol Hydrochloride Tablets USP, 100 mg are available as white to off-white, round, biconvex, film-coated tablets, debossed with ‘LU’ on one side and ‘C31’ on the other side.

They are supplied as follows:

NDC 68180-280-01 Bottles of 100’s

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 68180-281-01 Bottles of 100’s

NDC 68180-281-02 Bottles of 500’s

NDC 68180-281-13 4 x 14’s unit dose blisters

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.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

MADE IN INDIA

Revised: June 2021 ID# 267598

PRINCIPAL DISPLAY PANEL

ETHAMBUTOL HYDROCHLORIDE TABLETS USP

Rx Only

100 mg

NDC 68180-280-01

100 Tablets

Ethambutol 100 mg
(click image for full-size original)

ETHAMBUTOL HYDROCHLORIDE TABLETS USP

Rx Only

400 mg

NDC 68180-281-01

100 Tablets

Ethambutol HCl Tabs USP, 400 mg
(click image for full-size original)
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-280
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL) ETHAMBUTOL HYDROCHLORIDE 100 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 no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code LU;C31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-280-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078939 07/10/2009
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:68180-281-01 100 TABLET in 1 BOTTLE None
2 NDC:68180-281-02 500 TABLET in 1 BOTTLE None
3 NDC:68180-281-13 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68180-281-11)
3 NDC:68180-281-11 14 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68180-281-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078939 07/04/2009
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (68180-280), MANUFACTURE (68180-281), PACK (68180-280), PACK (68180-281)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650759348 MANUFACTURE (68180-280), MANUFACTURE (68180-281), PACK (68180-280), PACK (68180-281)

Revised: 06/2021 Lupin Pharmaceuticals, Inc.

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