NDC 0406-1010

OXYMORPHONE HYDROCHLORIDE

Oxymorphone Hydrochloride

OXYMORPHONE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Oxymorphone Hydrochloride.

• Product ID: 0406-1010_0c2957c6-5714-416c-9afb-98ee965950f7
• NDC: 0406-1010
• Product Type: Human Prescription Drug
• Proprietary Name: OXYMORPHONE HYDROCHLORIDE
• Generic Name: Oxymorphone Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-04-25
• Marketing End Date: 2021-05-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202321
• Labeler Name: SpecGx LLC
• Substance Name: OXYMORPHONE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 0406-1010-01

100 TABLET in 1 BOTTLE (0406-1010-01)

• Marketing Start Date: 2013-04-25
• Marketing End Date: 2021-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0406-1010-01 [00406101001]

OXYMORPHONE HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA202321
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-04-25
• Marketing End Date: 2021-05-31

Drug Details

Active Ingredients

Ingredient	Strength
OXYMORPHONE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 9281b012-ee14-4992-ba6a-ae91180b6f95
• Manufacturer:
  • SpecGx LLC
• UNII:
  • 5Y2EI94NBC
• RxNorm Concept Unique ID - RxCUI:
  • 977942
  • 977939
• UPC Code:
  • 0304061010016
  • 0304061009010

Pharmacological Class

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

NDC Crossover Matching brand name "OXYMORPHONE HYDROCHLORIDE" or generic name "Oxymorphone Hydrochloride"

NDC	Brand Name	Generic Name
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
10702-071	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
10702-070	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
13107-103	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
13107-104	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
31722-929	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
31722-930	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
35356-968	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
35356-967	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
55700-387	Oxymorphone hydrochloride	Oxymorphone hydrochloride
55700-215	Oxymorphone hydrochloride	Oxymorphone hydrochloride
55700-417	Oxymorphone hydrochloride	Oxymorphone hydrochloride
55700-423	Oxymorphone hydrochloride	Oxymorphone hydrochloride
60951-794	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
60951-795	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
63304-224	Oxymorphone hydrochloride	Oxymorphone hydrochloride
63304-221	Oxymorphone hydrochloride	Oxymorphone hydrochloride
63304-222	Oxymorphone hydrochloride	Oxymorphone hydrochloride
63304-218	Oxymorphone hydrochloride	Oxymorphone hydrochloride
63304-219	Oxymorphone hydrochloride	Oxymorphone hydrochloride
63304-220	Oxymorphone hydrochloride	Oxymorphone hydrochloride
63304-223	Oxymorphone hydrochloride	Oxymorphone hydrochloride
0406-1010	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
0406-1009	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
42806-331	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
42806-330	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride
64896-700	Oxymorphone hydrochloride	Oxymorphone hydrochloride
64896-701	Oxymorphone hydrochloride	Oxymorphone hydrochloride
64896-695	Oxymorphone hydrochloride	Oxymorphone hydrochloride
64896-699	Oxymorphone hydrochloride	Oxymorphone hydrochloride
64896-698	Oxymorphone hydrochloride	Oxymorphone hydrochloride
64896-696	Oxymorphone hydrochloride	Oxymorphone hydrochloride
64896-697	Oxymorphone hydrochloride	Oxymorphone hydrochloride