CHLORPROMAZINE HYDROCHLORIDE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P)

Dostupné z:

Zydus Lifesciences Limited

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depr

Prehľad produktov:

Chlorpromazine hydrochloride tablets USP, 10 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "29" on other side. NDC 70771-1506-1 in bottles of 100 tablets NDC 70771-1506-4 in unit-dose blister cartons of 100 Tablets (10 x 10 Unit-dose) Chlorpromazine hydrochloride tablets, USP, 25 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "30" on other side. NDC 70771-1507-1 in bottles of 100 tablets NDC 70771-1507-4 in unit-dose blister cartons of 100 Tablets (10 x 10 Unit-dose) Chlorpromazine hydrochloride tablets, USP, 50 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "31"on other side. NDC 70771-1508-1 in bottles of 100 tablets NDC 70771-1508-4 in unit-dose blister cartons of 100 Tablets (10 x 10 Unit-dose) THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine hydrochloride tablets, USP, 100 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "32" on other side. NDC 70771-1509-1 in bottles of 100 tablets NDC 70771-1509-4 in unit-dose blister cartons of 100 Tablets (10 x 10 Unit-dose) Chlorpromazine hydrochloride tablets, USP, 200 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "33"on other side. NDC 70771-1510-1 in bottles of 100 tablets NDC 70771-1510-4 in unit-dose blister cartons of 100 Tablets (10 x 10 Unit-dose) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Unit-dose package is not for household dispensing. If dispensed for outpatient use, a well closed, light-resistant, child-resistant container should be utilized. Keep this and all drugs out of the reach of children. Manufactured by: Cadila Healthcare Ltd., India Rev.: 01/20

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET,
FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
CHLORPROMAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1506-1
ChlorproMAZINE Hydrochloride Tablets, USP
10 mg
100 Tablets
Rx only
NDC 70771-1507-1
ChlorproMAZINE Hydrochloride Tablets, USP
25 mg
100 Tablets
Rx only
NDC 70771-1508-1
ChlorproMAZINE Hydrochloride Tablets, USP
50 mg
100 Tablets
Rx only
NDC 70771-1509-1
ChlorproMAZINE Hydrochloride Tablets, USP
100 mg
100 Tablets
Rx only
NDC 70771-1510-1
ChlorproMAZINE Hydrochloride Tablets, USP
200 mg
100 Tablets
Rx only
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1506
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6)
(CHLORPROMAZINE - UNII:U42B7VYA4P)
CHLORPROMAZ INE
HYDROCHLORIDE
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
BROWN
SCORE
no score
SHAPE
ROUND
SIZE
6mm
FLAVOR
IMPRINT CODE
11;29
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1506-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
01/27/2020
2
NDC:70771-
1506-4
10 in 1 CARTON
01/27/2020
2
NDC:70771-
1506-2
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING I