azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler quality care products, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 250 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-081
Product ID 83008-081_ba400da0-efae-451a-91d4-b9f5ad4dc773
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208250
Marketing Start 2024-08-28
Marketing End 2027-01-02

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008081
Hyphenated Format 83008-081

Supplemental Identifiers

RxCUI
308460 749783
UNII
5FD1131I7S

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 dihydrate (source: ndc)
Generic Name azithromycin dihydrate (source: ndc)
Application Number ANDA208250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (83008-081-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

83008-081-06 1 BLISTER PACK in 1 CARTON (83008-081-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

azithromycin dihydrate (250 mg/1)

Linked Drug Pages (1)

Azithromycin Dihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ba400da0-efae-451a-91d4-b9f5ad4dc773", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["308460", "749783"], "spl_set_id": ["2065c4ba-e3f5-41a2-b3d5-205dab646924"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (83008-081-06)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "83008-081-06", "marketing_end_date": "20270102", "marketing_start_date": "20240828"}], "brand_name": "Azithromycin Dihydrate", "product_id": "83008-081_ba400da0-efae-451a-91d4-b9f5ad4dc773", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "83008-081", "generic_name": "Azithromycin Dihydrate", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin Dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA208250", "marketing_category": "ANDA", "marketing_end_date": "20270102", "marketing_start_date": "20240828"}