NDC 63481-816

Opana ER

Oxymorphone Hydrochloride

Opana ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Oxymorphone Hydrochloride.

• Product ID: 63481-816_78824d02-9c7b-45ce-8030-48bc1d817cc6
• NDC: 63481-816
• Product Type: Human Prescription Drug
• Proprietary Name: Opana ER
• Generic Name: Oxymorphone Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2012-03-20
• Marketing End Date: 2019-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA201655
• Labeler Name: Endo Pharmaceuticals, Inc.
• Substance Name: OXYMORPHONE HYDROCHLORIDE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 63481-816-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63481-816-60)

• Marketing Start Date: 2012-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63481-816-70 [63481081670]

Opana ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201655
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-03-20
• Marketing End Date: 2012-03-20

NDC 63481-816-60 [63481081660]

Opana ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201655
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-03-20
• Marketing End Date: 2019-08-01

NDC 63481-816-20 [63481081620]

Opana ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201655
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-03-20
• Marketing End Date: 2014-10-31

Drug Details

Active Ingredients

Ingredient	Strength
OXYMORPHONE HYDROCHLORIDE	20 mg/1

OpenFDA Data

• SPL SET ID: e6e34c18-fbc6-4cab-9aed-0905d93c2ab6
• Manufacturer:
  • Endo Pharmaceuticals, Inc.
• UNII:
  • 5Y2EI94NBC
• RxNorm Concept Unique ID - RxCUI:
  • 977931
  • 977894
  • 977917
  • 977896
  • 977915
  • 977904
  • 977923
  • 977902
  • 977925
  • 977929
  • 977911
  • 977876
  • 977874
  • 977909
• UPC Code:
  • 0363481818602
  • 0363481817605
  • 0363481812600
  • 0363481814604
  • 0363481816608
  • 0363481815601
  • 0363481813607

Pharmacological Class

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

Medicade Reported Pricing

63481081660 OPANA ER 20 MG TABLET

Pricing Unit: EA | Drug Type:

63481081620 OPANA ER 20 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Opana ER" or generic name "Oxymorphone Hydrochloride"

NDC	Brand Name	Generic Name
21695-948	OPANA ER	OPANA ER
21695-949	OPANA ER	OPANA ER
35356-825	Opana ER	Opana ER
35356-848	Opana ER	Opana ER
35356-849	Opana ER	Opana ER
35356-820	Opana ER	Opana ER
63481-816	Opana ER	Opana ER
63481-817	Opana ER	Opana ER
63481-814	Opana ER	Opana ER
63481-815	Opana ER	Opana ER
63481-818	Opana ER	Opana ER
63481-812	Opana ER	Opana ER
63481-813	Opana ER	Opana ER
63629-4174	Opana ER	Opana ER
63629-4177	OPANA ER	OPANA ER
0054-0283	Oxymorphone Hydrochloride	oxymorphone hydrochloride
0054-0284	Oxymorphone Hydrochloride	oxymorphone hydrochloride
0115-1231	Oxymorphone hydrochloride	Oxymorphone hydrochloride
0115-1232	Oxymorphone hydrochloride	Oxymorphone hydrochloride
0115-1233	Oxymorphone hydrochloride	Oxymorphone hydrochloride
0115-1234	Oxymorphone hydrochloride	Oxymorphone hydrochloride
0115-1315	Oxymorphone hydrochloride	Oxymorphone hydrochloride
0115-1316	Oxymorphone hydrochloride	Oxymorphone hydrochloride
0115-1317	Oxymorphone hydrochloride	Oxymorphone hydrochloride