azithromycin

Generic: azithromycin

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler nucare pharmaceuticals,inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin monohydrate 100 mg/5mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5035
Product ID 68071-5035_1b411fb5-14de-2e1d-e063-6294a90a3ec9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207531
Listing Expiration 2026-12-31
Marketing Start 2018-04-10

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680715035
Hyphenated Format 68071-5035

Supplemental Identifiers

RxCUI
308459
UPC
0368071503555
UNII
JTE4MNN1MD

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name azithromycin (source: ndc)
Generic Name azithromycin (source: ndc)
Application Number ANDA207531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (68071-5035-5)
source: ndc

Packages (1)

68071-5035-5 15 mL in 1 BOTTLE (68071-5035-5)

Ingredients (1)

azithromycin monohydrate (100 mg/5mL)

Linked Drug Pages (1)

AZITHROMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b411fb5-14de-2e1d-e063-6294a90a3ec9", "openfda": {"upc": ["0368071503555"], "unii": ["JTE4MNN1MD"], "rxcui": ["308459"], "spl_set_id": ["90a506cd-aae7-a622-e053-2a95a90ad352"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (68071-5035-5)", "package_ndc": "68071-5035-5", "marketing_start_date": "20190821"}], "brand_name": "AZITHROMYCIN", "product_id": "68071-5035_1b411fb5-14de-2e1d-e063-6294a90a3ec9", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68071-5035", "generic_name": "AZITHROMYCIN", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZITHROMYCIN", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "100 mg/5mL"}], "application_number": "ANDA207531", "marketing_category": "ANDA", "marketing_start_date": "20180410", "listing_expiration_date": "20261231"}