COSYNTROPIN (Page 2 of 2)

HOW SUPPLIED

Cosyntropin for Injection 0.25 mg is supplied as under:


NDC # 0781-3440-95 Box of 10 vials

Storage

Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Excursions permitted to 15° to 30°C (59° to 86°F).

Cosyntropin for Injection is lyophilized, single dose vial for diagnostic use only. It contains no antimicrobial preservative. Any unused portion should be discarded.

Rx only

REFERENCES

1. Wood, J.B. et al. LANCET 1.243, 1965.

2. Greig, W.R. et al. J. ENDOCR 34.411, 1966.

3. McGill, P.E. et al. ANN RHEUM DIS 26.123, 1967.

Manufactured by

Oakwood Labs, Solon, Ohio for

Sandoz Inc., Princeton, NJ

Rev. July 2012

PRINCIPAL DISPLAY PANEL — 51662-1567-1 — VIAL AND SERIALIZED VIAL LABELING

Vial Labeling
(click image for full-size original)
Serialized Labeling
(click image for full-size original)
COSYNTROPIN
cosyntropin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1567(NDC:0781-3440)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COSYNTROPIN (COSYNTROPIN) COSYNTROPIN 0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1567-1 1 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202147 07/10/2021
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 (51662-1567)

Revised: 07/2021 HF Acquisition Co LLC, DBA HealthFirst

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