NDC 0406-3332

Hydromorphone Hydrochloride Extended-Release

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Hydromorphone Hydrochloride.

• Product ID: 0406-3332_123d99b6-2d52-4491-944c-f73b9d6387b8
• NDC: 0406-3332
• Product Type: Human Prescription Drug
• Proprietary Name: Hydromorphone Hydrochloride Extended-Release
• Generic Name: Hydromorphone Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-06-12
• Marketing End Date: 2021-03-31
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021217
• Labeler Name: SpecGx LLC
• Substance Name: HYDROMORPHONE HYDROCHLORIDE
• Active Ingredient Strength: 32 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 0406-3332-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3332-01)

• Marketing Start Date: 2014-05-16
• Marketing End Date: 2021-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0406-3332-01 [00406333201]

Hydromorphone Hydrochloride Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA021217
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-06-12
• Marketing End Date: 2021-03-31

Drug Details

Active Ingredients

Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	32 mg/1

OpenFDA Data

• SPL SET ID: 0f522b18-ce6d-4fc7-8bc7-5b2ea2dd3840
• Manufacturer:
  • SpecGx LLC
• UNII:
  • L960UP2KRW
• RxNorm Concept Unique ID - RxCUI:
  • 1306898
  • 902736
  • 902741
  • 902729
• UPC Code:
  • 0304063308012
  • 0304063316017
  • 0304063332017
  • 0304063312019

Pharmacological Class

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

NDC Crossover Matching brand name "Hydromorphone Hydrochloride Extended-Release" or generic name "Hydromorphone Hydrochloride"

NDC	Brand Name	Generic Name
0054-0264	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0054-0265	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0054-0386	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0406-3308	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride
0406-3312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride
0406-3316	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride
0406-3332	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE