NDC 54738-901

Quinidine Gluconate

Quinidine Gluconate

Quinidine Gluconate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Richmond Pharmaceuticals, Inc.. The primary component is Quinidine Gluconate.

• Product ID: 54738-901_09624157-b39f-4a90-9651-17eeac2ce39c
• NDC: 54738-901
• Product Type: Human Prescription Drug
• Proprietary Name: Quinidine Gluconate
• Generic Name: Quinidine Gluconate
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1987-02-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA089338
• Labeler Name: Richmond Pharmaceuticals, Inc.
• Substance Name: QUINIDINE GLUCONATE
• Active Ingredient Strength: 324 mg/1
• Pharm Classes: Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54738-901-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54738-901-01)

• Marketing Start Date: 1987-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54738-901-01 [54738090101]

Quinidine Gluconate TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA089338
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-02-10

NDC 54738-901-02 [54738090102]

Quinidine Gluconate TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA089338
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-02-10

Drug Details

Active Ingredients

Ingredient	Strength
QUINIDINE GLUCONATE	324 mg/1

OpenFDA Data

• SPL SET ID: 4fb02ad7-6e93-4aff-9aca-5162559b99a5
• Manufacturer:
  • Richmond Pharmaceuticals, Inc.
• UNII:
  • R6875N380F
• RxNorm Concept Unique ID - RxCUI:
  • 852920

Pharmacological Class

• Antiarrhythmic [EPC]
• Cytochrome P450 2D6 Inhibitor [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Antiarrhythmic [EPC]
• Cytochrome P450 2D6 Inhibitor [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]

NDC Crossover Matching brand name "Quinidine Gluconate" or generic name "Quinidine Gluconate"

NDC	Brand Name	Generic Name
0002-1407	Quinidine Gluconate	Quinidine Gluconate
51407-288	Quinidine Gluconate	Quinidine Gluconate
53489-141	Quinidine Gluconate	Quinidine Gluconate
54738-901	Quinidine Gluconate	Quinidine Gluconate
68151-2701	Quinidine Gluconate	Quinidine Gluconate
71930-016	Quinidine gluconate	Quinidine gluonate