Zolmitriptan (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 2.5 mg Blister Carton

Rising®
PHARMACEUTICALS
NDC 16571-803-16
Zolmitriptan Tablets, USP
2.5 mg
6 (1 x 6) Unit-dose Tablets Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -- 2.5 mg Blister Carton
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 5 mg Blister Carton

Rising® NDC 16571-804-13
PHARMACEUTICALS
Zolmitriptan Tablets, USP
5 mg

3 (1 x 3) Unit-dose Tablets Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -- 5 mg Blister Carton
(click image for full-size original)

ZOLMITRIPTAN zolmitriptan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-803
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLMITRIPTAN (ZOLMITRIPTAN) ZOLMITRIPTAN 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code C;C;37
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16571-803-16 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (16571-803-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207021 05/11/2016
ZOLMITRIPTAN zolmitriptan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-804
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLMITRIPTAN (ZOLMITRIPTAN) ZOLMITRIPTAN 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code CC;51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16571-804-13 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (16571-804-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207021 05/11/2016
Labeler — Rising Pharma Holdings, Inc. (835513529)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (16571-803), ANALYSIS (16571-804), MANUFACTURE (16571-803), MANUFACTURE (16571-804)

Revised: 09/2021 Rising Pharma Holdings, Inc.

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