NDC 58914-601

Pylera

Bismuth Subcitrate Potassium, Metronidazole, Tetracycline Hydrochloride

Pylera is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride.

• Product ID: 58914-601_5496a567-bd63-4063-a95a-7addc47665f1
• NDC: 58914-601
• Product Type: Human Prescription Drug
• Proprietary Name: Pylera
• Generic Name: Bismuth Subcitrate Potassium, Metronidazole, Tetracycline Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA050786
• Labeler Name: Allergan, Inc.
• Substance Name: BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
• Active Ingredient Strength: 140 mg/1; mg/1; mg/1
• Pharm Classes: Bismuth [CS],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS],Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 58914-601-20

1 BLISTER PACK in 1 BOX (58914-601-20) > 120 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2013-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58914-601-20 [58914060120]

Pylera CAPSULE

• Marketing Category: NDA
• Application Number: NDA050786
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-08-01

NDC 58914-601-21 [58914060121]

Pylera CAPSULE

• Marketing Category: NDA
• Application Number: NDA050786
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-08-01

Drug Details

Active Ingredients

Ingredient	Strength
BISMUTH SUBCITRATE POTASSIUM	140 mg/1

OpenFDA Data

• SPL SET ID: a762e164-b390-4e8c-bd46-bf6c31eeb486
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • P6R62377KV
  • 140QMO216E
  • R3O80H60KX
• RxNorm Concept Unique ID - RxCUI:
  • 1294621
  • 1294619

Pharmacological Class

• Bismuth [CS]
• Bismuth [EPC]
• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]
• Tetracycline-class Antimicrobial [EPC]
• Tetracyclines [CS]
• Bismuth [CS]
• Bismuth [EPC]
• Nitroimidazole Antimicrobial [EPC]
• Nitroimidazoles [CS]
• Tetracycline-class Antimicrobial [EPC]
• Tetracyclines [CS]

Medicade Reported Pricing

58914060120 PYLERA CAPSULE

Pricing Unit: EA | Drug Type: