NDC 0591-0395

Pentazocine and naloxone

Pentazocine Hydrochloride And Naloxone Hydrochloride

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

• Product ID: 0591-0395_23c66a22-a657-442f-8ea3-1f8dcde4a37e
• NDC: 0591-0395
• Product Type: Human Prescription Drug
• Proprietary Name: Pentazocine and naloxone
• Generic Name: Pentazocine Hydrochloride And Naloxone Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1997-05-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074736
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: PENTAZOCINE HYDROCHLORIDE; 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 0591-0395-01

100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01)

• Marketing Start Date: 1997-05-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-0395-01 [00591039501]

Pentazocine and Naloxone TABLET

• Marketing Category: ANDA
• Application Number: ANDA074736
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-05-21

Drug Details

Active Ingredients

Ingredient	Strength
PENTAZOCINE HYDROCHLORIDE	50 mg/1

OpenFDA Data

• SPL SET ID: a28450a0-ac93-4235-b9a6-58cdf24773cb
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • A36BXO4PPX
  • F850569PQR
• RxNorm Concept Unique ID - RxCUI:
  • 312289

Pharmacological Class

• 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 Hydrochloride And Naloxone Hydrochloride"

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
43386-680	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	pentazocine hydrochloride and naloxone hydrochloride
61919-556	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE