HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]

HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]
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NDC	52533-005-10
Set ID	c4a6f07e-f242-4d25-be44-743b185783a1
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Cantrell Drug Company
Generic Name
Product Class
Product Number
Application Number

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PRINCIPAL DISPLAY PANEL
SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

HYDROMORPHONE HCL
hydromorphone hcl injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:52533-005
Route of Administration	INTRAVENOUS	DEA Schedule	CII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)	HYDROMORPHONE HYDROCHLORIDE	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Sodium Chloride (UNII: 451W47IQ8X)	9 mg in 1 mL
WATER (UNII: 059QF0KO0R)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
May contain	HYDROCHLORIC ACID (UNII: QTT17582CB)
May contain	SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52533-005-10	30 mL in 1 VIAL, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/13/2014

Labeler - Cantrell Drug Company (035545763)

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