AMINOPHYLLINE (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Label

20 mL Single-dose

Aminophylline
Injection, USP

500 mg/20 mL (25 mg/mL)

Protect from light.

DO NOT USE IF CRYSTALS HAVE SEPARATED FROM SOLUTION.

VIAL LABEL
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PRINCIPAL DISPLAY PANEL — SERIALIZED 20 mL Vial Label

SERIALIZED LABEL
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PRINCIPAL DISPLAY PANEL — NDC 0409-5922-16 VIAL LABEL

Vial Label -16
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Principal Display Panel — 51662-1341-2 — Pouch Labeling

Pouch Labeling
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Principal Display Panel — 51662-1341-3 — Case Labeling

RFID Labeling
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Case Labeling
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AMINOPHYLLINE aminophylline injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1341(NDC:0409-5922)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMINOPHYLLINE DIHYDRATE (THEOPHYLLINE ANHYDROUS) AMINOPHYLLINE DIHYDRATE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ETHYLENEDIAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1341-1 20 mL in 1 VIAL, SINGLE-DOSE None
2 NDC:51662-1341-3 25 POUCH in 1 CASE contains a POUCH (51662-1341-2)
2 NDC:51662-1341-2 1 mL in 1 POUCH This package is contained within the CASE (51662-1341-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087242 02/10/2019
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1341)

Revised: 02/2021 HF Acquisition Co LLC, DBA HealthFirst

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