Sumatriptan and Naproxen Sodium (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65862-928-36
Rx only
Sumatriptan and Naproxen
Sodium Tablets
85 mg/500 mg
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
J78
AUROBINDO 9 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
(click image for full-size original)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SUMATRIPTAN AND NAPROXEN SODIUM sumatriptan and naproxen sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-928
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 85 mg
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
DEXTROSE MONOHYDRATE
LECITHIN, SOYBEAN
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POVIDONE K90
SODIUM BICARBONATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape CAPSULE (Modified Capsule Shaped) Size 22mm
Flavor Imprint Code J78
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-928-36 9 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207457 02/15/2018
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-928), MANUFACTURE (65862-928)

Revised: 05/2021 Aurobindo Pharma Limited

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