NDC 61919-391

AUGMENTIN

Amox/clav.pot.oral Susp

AUGMENTIN is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Direct_rx. The primary component is Amoxicillin; Clavulanic Acid.

• Product ID: 61919-391_36fb1fec-f0f6-6d2f-e054-00144ff88e88
• NDC: 61919-391
• Product Type: Human Prescription Drug
• Proprietary Name: AUGMENTIN
• Generic Name: Amox/clav.pot.oral Susp
• Dosage Form: Powder, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2015-11-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065191
• Labeler Name: Direct_Rx
• Substance Name: AMOXICILLIN; CLAVULANIC ACID
• Active Ingredient Strength: 400 mg/5mL; mg/5mL
• Pharm Classes: Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61919-391-32

5 mL in 1 BOTTLE (61919-391-32)

• Marketing Start Date: 2015-11-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-391-32 [61919039132]

AUGMENTIN POWDER, FOR SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA065191
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-11-09

Drug Details

Active Ingredients

Ingredient	Strength
AMOXICILLIN	400 mg/5mL

OpenFDA Data

• SPL SET ID: 36fb1fec-f0f5-6d2f-e054-00144ff88e88
• Manufacturer:
  • Direct_Rx
• UNII:
  • 23521W1S24
  • 804826J2HU
• RxNorm Concept Unique ID - RxCUI:
  • 617430
  • 617432

Pharmacological Class

• Penicillin-class Antibacterial [EPC]
• Penicillins [CS]
• beta Lactamase Inhibitor [EPC]
• beta Lactamase Inhibitors [MoA]

NDC Crossover Matching brand name "AUGMENTIN" or generic name "Amox/clav.pot.oral Susp"

NDC	Brand Name	Generic Name
43598-004	AUGMENTIN	amoxicillin and clavulanate potassium
43598-006	AUGMENTIN	amoxicillin and clavulanate potassium
43598-012	AUGMENTIN	amoxicillin and clavulanate potassium
43598-018	AUGMENTIN	amoxicillin and clavulanate potassium
43598-021	AUGMENTIN	amoxicillin and clavulanate potassium
61919-391	AUGMENTIN	AMOX/CLAV.POT.ORAL SUSP
72508-004	AUGMENTIN	amoxicillin and clavulanate potassium
72508-006	AUGMENTIN	amoxicillin and clavulanate potassium
72508-012	AUGMENTIN	amoxicillin and clavulanate potassium
72508-018	AUGMENTIN	amoxicillin and clavulanate potassium
72508-021	AUGMENTIN	amoxicillin and clavulanate potassium