azithromycin

Generic: azithromycin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin monohydrate 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0599
Product ID 70518-0599_47fa21e2-07c3-16d5-e063-6394a90abf0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065223
Listing Expiration 2027-12-31
Marketing Start 2017-06-28

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705180599
Hyphenated Format 70518-0599

Supplemental Identifiers

RxCUI
248656
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 ANDA065223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 2 POUCH in 1 BOX (70518-0599-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-0599-6)
  • 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-3)
source: ndc

Packages (2)

70518-0599-0 2 POUCH in 1 BOX (70518-0599-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-0599-6) 70518-0599-3 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-3)

Ingredients (1)

azithromycin monohydrate (500 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": "47fa21e2-07c3-16d5-e063-6394a90abf0d", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["248656"], "spl_set_id": ["943b9246-7733-44b1-875c-91d2ade78ac4"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "2 POUCH in 1 BOX (70518-0599-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-0599-6)", "package_ndc": "70518-0599-0", "marketing_start_date": "20170628"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-3)", "package_ndc": "70518-0599-3", "marketing_start_date": "20200423"}], "brand_name": "Azithromycin", "product_id": "70518-0599_47fa21e2-07c3-16d5-e063-6394a90abf0d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70518-0599", "generic_name": "Azithromycin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065223", "marketing_category": "ANDA", "marketing_start_date": "20170628", "listing_expiration_date": "20271231"}