Caffeine Citrate (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Injection 3 mL vial label

NDC 47335-289-40
Caffeine Citrate
Injection, USP
60 mg/3 mL (20 mg/mL)
For Intravenous Use Only
For single use only;
discard unused portion. Rx only

spl-caffeine-label-1
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Injection- 1 vial carton — 3 ml single dose vial

NDC 47335-289-40
Caffeine Citrate
Injection, USP
60 mg/3 mL (20 mg/mL)
For Intravenous Use Only
For Single Use Only.
Discard Unused Portion.
Rx only SUN PHARMA

spl-caffeine-carton-1
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — SOLUTION — 3 mL vial label

NDC 47335-290-40
Caffeine Citrate
Oral Solution, USP
60 mg/3 mL (20 mg/mL)
For Oral Use Only
For single use only; discard unused potion.
3 mL Vial Rx only

spl-caffeine-label-2
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spl-caffeine-label-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — SOLUTION — 10 vial Container — 3 mLs ingle dos e vials

NDC 47335-290-44
Caffeine Citrate
Oral Solution, USP
60 mg/3 mL (20 mg/mL)
For Oral Use Only
For single use only; discard unused portion.
Rx only
SUN PHARMA
10 x 3 mL Single-Dose Vials PHARMACIST: Dispense the drug product with the patient information leaflet

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CAFFEINE CITRATE caffeine citrate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-289
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE CITRATE (CAFFEINE) CAFFEINE CITRATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
TRISODIUM CITRATE DIHYDRATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-289-40 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 3 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (47335-289-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090077 10/01/2009 02/25/2021
CAFFEINE CITRATE caffeine citrate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-290
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE CITRATE (CAFFEINE) CAFFEINE CITRATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
TRISODIUM CITRATE DIHYDRATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-290-44 10 VIAL, SINGLE-DOSE in 1 CONTAINER contains a VIAL, SINGLE-DOSE (47335-290-40)
1 NDC:47335-290-40 3 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CONTAINER (47335-290-44)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090357 03/01/2021
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (47335-289), ANALYSIS (47335-290), MANUFACTURE (47335-289), MANUFACTURE (47335-290)

Revised: 12/2020 Sun Pharmaceutical Industries, Inc.

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