Sumatriptan Succinate (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Sumatriptan succinate

GENERIC: Sumatriptan succinate

DOSAGE: Injection

ADMINSTRATION: subcutaneous

NDC: 64679-728-08

STRENGTH: 6 mg (base)/0.5 mL

QTY: 0.5 mL Single-Dose Vial Label

Vial label
(click image for full-size original)
SUMATRIPTAN SUCCINATE sumatriptan succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-728
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 6 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Product Characteristics
Color YELLOW (clear, colorless to pale yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-728-01 5 VIAL in 1 CARTON contains a VIAL (64679-728-08)
1 NDC:64679-728-08 0.5 mL in 1 VIAL This package is contained within the CARTON (64679-728-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078593 02/06/2009
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 ANALYSIS (64679-728), MANUFACTURE (64679-728), LABEL (64679-728), PACK (64679-728)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 858971074 ANALYSIS (64679-728), LABEL (64679-728), MANUFACTURE (64679-728), PACK (64679-728)

Revised: 11/2019 Wockhardt USA LLC.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.