CARBIDOPA tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH)

Available from:

Zydus Lifesciences Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carbidopa is indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Carbidopa is for use with carbidopa-levodopa in patients for whom the dosage of carbidopa-levodopa provides less than adequate daily dosage (usually 70 mg daily) of carbidopa. Carbidopa is for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each medication. Carbidopa is used with carbidopa-levodopa or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting, more rapid dosage titration, and with a somewhat smoother response. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from the addition of carbidopa.

Product summary:

Carbidopa Tablets 25 mg, are mottled orange round uncoated tablet debossed "1221" on flat side and scored on convex side and are supplied as:   NDC 70771-1355-1 in bottle of 100 tablets Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature] Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, ([e-mail]) Tel.: [phone].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBIDOPA - CARBIDOPA TABLET
ZYDUS LIFESCIENCES LIMITED
----------
CARBIDOPA TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1355-1
Carbidopa Tablets
Rx only
100 Tablets
CARBIDOPA
carbidopa tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1355
ROUTE OF ADMINISTRATION
ORAL
Zydus Lifesciences Limited
ROUTE OF ADMINISTRATION
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH)
CARBIDOPA ANHYDROUS
25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
PRODUCT CHARACTERISTICS
COLOR
ORANGE (MOTTLED ORANGE)
SCORE
2 pieces
SHAPE
ROUND (ROUND)
SIZE
8mm
FLAVOR
IMPRINT CODE
1221
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1355-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
09/06/2018
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA209910
09/06/2018
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
863362789
ANALYSIS(70771-1355) , MANUFACTURE(70771-1355)
Revised: 10/2022