NDC 0093-7148

Azithromycin

Azithromycin Monohydrate

Azithromycin is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Azithromycin Monohydrate.

• Product ID: 0093-7148_98f701e6-6825-4360-8cdb-6d91f5962a75
• NDC: 0093-7148
• Product Type: Human Prescription Drug
• Proprietary Name: Azithromycin
• Generic Name: Azithromycin Monohydrate
• Dosage Form: Powder, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2008-09-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065419
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• Substance Name: AZITHROMYCIN MONOHYDRATE
• Active Ingredient Strength: 100 mg/5mL
• Pharm Classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0093-7148-23

15 mL in 1 BOTTLE (0093-7148-23)

• Marketing Start Date: 2008-09-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-7148-23 [00093714823]

Azithromycin POWDER, FOR SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA065419
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-09-22
• Marketing End Date: 2015-11-30

Drug Details

Active Ingredients

Ingredient	Strength
AZITHROMYCIN MONOHYDRATE	100 mg/5mL

OpenFDA Data

• SPL SET ID: 4d8b1cba-b6ed-4036-8307-28da2322ccd5
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • JTE4MNN1MD
• RxNorm Concept Unique ID - RxCUI:
  • 308459
  • 141963

Pharmacological Class

• Macrolide Antimicrobial [EPC]
• Macrolides [CS]

NDC Crossover Matching brand name "Azithromycin" or generic name "Azithromycin Monohydrate"

NDC	Brand Name	Generic Name
0093-2026	Azithromycin	Azithromycin
0093-2027	Azithromycin	Azithromycin
0093-7146	Azithromycin	Azithromycin
0093-7147	Azithromycin	Azithromycin
0093-7148	Azithromycin	Azithromycin Monohydrate
0093-7149	Azithromycin	Azithromycin Monohydrate
0093-7169	Azithromycin	Azithromycin
0409-0144	Azithromycin	AZITHROMYCIN
0527-2370	azithromycin	AZITHROMYCIN MONOHYDRATE
0527-2381	azithromycin	AZITHROMYCIN MONOHYDRATE
0527-2395	azithromycin	AZITHROMYCIN MONOHYDRATE
0781-1496	Azithromycin	Azithromycin
0781-1497	Azithromycin	Azithromycin
0781-1941	Azithromycin	Azithromycin
0781-5776	Azithromycin	Azithromycin
0781-5789	Azithromycin	Azithromycin
68071-1323	Azithromycin	Azithromycin
68071-1528	Azithromycin	Azithromycin
68071-1584	Azithromycin	Azithromycin
68071-1527	Azithromycin	Azithromycin
68071-1873	Azithromycin	Azithromycin
68071-1392	Azithromycin	Azithromycin
68071-1605	Azithromycin	Azithromycin
68071-3006	Azithromycin	Azithromycin
68071-4106	Azithromycin	Azithromycin
68071-4255	Azithromycin	Azithromycin
68071-4364	Azithromycin	Azithromycin
68071-4680	Azithromycin	Azithromycin
68071-4785	Azithromycin	Azithromycin
68071-4795	AZITHROMYCIN	AZITHROMYCIN
68071-4786	Azithromycin	Azithromycin
68071-4774	Azithromycin	Azithromycin
68071-4711	Azithromycin	Azithromycin
68071-4773	AZITHROMYCIN	AZITHROMYCIN
68071-4779	Azithromycin	Azithromycin
68258-3051	azithromycin	azithromycin
68258-3012	AZITHROMYCIN	AZITHROMYCIN
68788-7082	Azithromycin	Azithromycin
68788-0713	azithromycin	azithromycin
68788-8939	Azithromycin	Azithromycin
68788-9046	Azithromycin	Azithromycin
68788-9077	Azithromycin	Azithromycin
68788-8947	Azithromycin	Azithromycin
68788-9958	Azithromycin	Azithromycin
68788-7066	Azithromycin	Azithromycin
68788-9045	Azithromycin	Azithromycin
68788-9311	Azithromycin	Azithromycin
68788-9038	azithromycin	azithromycin
68788-9078	Azithromycin	Azithromycin
68788-9959	Azithromycin	Azithromycin