NDC 72789-080

Moxifloxacin Hydrochloride Tablets, 400 mg

Moxifloxacin Hydrochloride Tablets, 400 Mg

Moxifloxacin Hydrochloride Tablets, 400 mg is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Moxifloxacin Hydrochloride Monohydrate.

• Product ID: 72789-080_a32ee932-1142-0d93-e053-2a95a90ab62c
• NDC: 72789-080
• Product Type: Human Prescription Drug
• Proprietary Name: Moxifloxacin Hydrochloride Tablets, 400 mg
• Generic Name: Moxifloxacin Hydrochloride Tablets, 400 Mg
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208682
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 72789-080-10

10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-080-10)

• Marketing Start Date: 2020-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72789-080-10 [72789008010]

Moxifloxacin Hydrochloride Tablets, 400 mg TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208682
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-10

Drug Details

Active Ingredients

Ingredient	Strength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE	400 mg/1

OpenFDA Data

• SPL SET ID: 5c2a9116-d6e4-429e-88bb-bb6bfedac2f0
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • B8956S8609
• RxNorm Concept Unique ID - RxCUI:
  • 311787
• UPC Code:
  • 0372789080109

Pharmacological Class

• Quinolone Antimicrobial [EPC]
• Quinolones [CS]

NDC Crossover Matching brand name "Moxifloxacin Hydrochloride Tablets, 400 mg" or generic name "Moxifloxacin Hydrochloride Tablets, 400 Mg"

NDC	Brand Name	Generic Name
69539-006	Moxifloxacin Hydrochloride Tablets, 400 mg	Moxifloxacin Hydrochloride Tablets, 400 mg
72205-001	Moxifloxacin Hydrochloride Tablets, 400 mg	Moxifloxacin Hydrochloride Tablets, 400 mg
72789-080	Moxifloxacin Hydrochloride Tablets, 400 mg	Moxifloxacin Hydrochloride Tablets, 400 mg