Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
Zydus Lifesciences Limited
BENZONATATE
BENZONATATE 100 mg
ORAL
PRESCRIPTION DRUG
Benzonatate capsules are indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.
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.
Abbreviated New Drug Application
BENZONATATE - BENZONATATE CAPSULE ZYDUS LIFESCIENCES LIMITED ---------- 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 Leggi il documento completo