NDC 52533-005

Hydromorphone HCl

Hydromorphone Hcl

Hydromorphone HCl is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cantrell Drug Company. The primary component is Hydromorphone Hydrochloride.

• Product ID: 52533-005_08860913-59ea-45da-ad52-3c89acfcea9f
• NDC: 52533-005
• Product Type: Human Prescription Drug
• Proprietary Name: Hydromorphone HCl
• Generic Name: Hydromorphone Hcl
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2013-10-11
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Cantrell Drug Company
• Substance Name: HYDROMORPHONE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 52533-005-05

30 mL in 1 VIAL, GLASS (52533-005-05)

• Marketing Start Date: 2012-01-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52533-005-45 [52533000545]

Hydromorphone HCl INJECTION, SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-11
• Inactivation Date: 2019-11-27

NDC 52533-005-10 [52533000510]

Hydromorphone HCl INJECTION, SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-08-13
• Inactivation Date: 2019-11-27

NDC 52533-005-05 [52533000505]

Hydromorphone HCl INJECTION, SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-01-18
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 55c85ab0-57d5-4820-b6b0-1d0e3381571c
• Manufacturer:
  • Cantrell Drug Company
• UNII:
  • L960UP2KRW

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "Hydromorphone HCl" or generic name "Hydromorphone Hcl"

NDC	Brand Name	Generic Name
52533-004	Hydromorphone HCl	Hydromorphone HCl
52533-005	Hydromorphone HCl	Hydromorphone HCl
52533-008	Hydromorphone HCl	Hydromorphone HCl
52533-145	Hydromorphone HCl	Hydromorphone HCl
52533-146	Hydromorphone HCl	Hydromorphone HCl