BENZONATATE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)

Tilgjengelig fra:

Zydus Lifesciences Limited

INN (International Name):

BENZONATATE

Sammensetning:

BENZONATATE 100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Benzonatate capsules are indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.

Produkt oppsummering:

Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "Z" containing pale yellow-colored clear viscous liquid and are supplied as follows: NDC 65841-614-01 in bottle of 100 capsules NDC 65841-614-05 in bottle of 500 capsules Benzonatate capsules USP, 200 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "β" containing pale yellow-colored clear viscous liquid and are supplied as follows: NDC 65841-615-01 in bottle of 100 capsules Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BENZONATATE - BENZONATATE CAPSULE
ZYDUS LIFESCIENCES LIMITED
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BENZONATATE CAPSULES, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-614-01 in bottle of 100 capsules
Benzonatate Capsules USP, 100 mg
R only
100 capsules
NDC 65841-843-01 in bottle of 100 capsules
Benzonatate Capsules USP, 200 mg
R only
100 capsules
x
x
BENZONATATE
benzonatate capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-614
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
BENZ ONATATE
100 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (LIGHT YELLOW)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
3mm
FLAVOR
IMPRINT CODE
Z
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-614-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
09/04/2007
2
NDC:65841-614-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
09/04/2007
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA040597
09/04/2007
BENZONATATE
benzonatate capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-843
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
BENZ ONATATE
200 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (LIGHT YELLOW)
SCORE
no score
SHAPE
OVAL (Oval)
SIZE
6mm
FLAVOR
IMPRINT CODE
B
CONTAINS
PACKAGING
Z