azithromycin

Generic: azithromycin

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 600 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-253
Product ID 46708-253_6a2f7a6c-a45d-448d-8f56-5bd7a5309a2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211793
Listing Expiration 2026-12-31
Marketing Start 2020-01-28

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708253
Hyphenated Format 46708-253

Supplemental Identifiers

RxCUI
204844
UPC
0346708253301
UNII
5FD1131I7S

Packaging Origin

Original Packager
true

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 ANDA211793 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (46708-253-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-253-30)
source: ndc

Packages (2)

46708-253-10 100 BLISTER PACK in 1 CARTON (46708-253-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 46708-253-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-253-30)

Ingredients (1)

azithromycin dihydrate (600 mg/1)

Linked Drug Pages (1)

AZITHROMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6a2f7a6c-a45d-448d-8f56-5bd7a5309a2d", "openfda": {"upc": ["0346708253301"], "unii": ["5FD1131I7S"], "rxcui": ["204844"], "spl_set_id": ["5dca5a11-3c02-4a51-a35d-f91f37b8e00c"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (46708-253-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46708-253-10", "marketing_start_date": "20200128"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-253-30)", "package_ndc": "46708-253-30", "marketing_start_date": "20200128"}], "brand_name": "AZITHROMYCIN", "product_id": "46708-253_6a2f7a6c-a45d-448d-8f56-5bd7a5309a2d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "46708-253", "generic_name": "AZITHROMYCIN", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZITHROMYCIN", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "600 mg/1"}], "application_number": "ANDA211793", "marketing_category": "ANDA", "marketing_start_date": "20200128", "listing_expiration_date": "20261231"}