NDC 63304-506

pentazocine and naloxone

Pentazocine And Naloxone

pentazocine and naloxone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Pentazocine; Naloxone Hydrochloride.

• Product ID: 63304-506_48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3
• NDC: 63304-506
• Product Type: Human Prescription Drug
• Proprietary Name: pentazocine and naloxone
• Generic Name: Pentazocine And Naloxone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075523
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: PENTAZOCINE; NALOXONE HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/1; mg/1
• Pharm Classes: Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63304-506-01

100 TABLET in 1 BOTTLE (63304-506-01)

• Marketing Start Date: 2018-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63304-506-01 [63304050601]

pentazocine and naloxone TABLET

• Marketing Category: ANDA
• Application Number: ANDA075523
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-31

Drug Details

Active Ingredients

Ingredient	Strength
PENTAZOCINE	50 mg/1

OpenFDA Data

• SPL SET ID: 41ebdaaf-3bbc-419f-b996-0341efc14623
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • RP4A60D26L
  • F850569PQR
• RxNorm Concept Unique ID - RxCUI:
  • 312289
• UPC Code:
  • 0363304506013

Pharmacological Class

• Competitive Opioid Antagonists [MoA]
• Partial Opioid Agonist/Antagonist [EPC]
• Partial Opioid Agonists [MoA]
• Opioid Antagonist [EPC]
• Opioid Antagonists [MoA]
• Competitive Opioid Antagonists [MoA]
• Partial Opioid Agonist/Antagonist [EPC]
• Partial Opioid Agonists [MoA]
• Opioid Antagonist [EPC]
• Opioid Antagonists [MoA]

NDC Crossover Matching brand name "pentazocine and naloxone" or generic name "Pentazocine And Naloxone"

NDC	Brand Name	Generic Name
0591-0395	Pentazocine and naloxone	Pentazocine hydrochloride and naloxone hydrochloride
63304-506	pentazocine and naloxone	pentazocine and naloxone
68387-531	Pentazocine and naloxone	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE