azithromycin

Generic: azithromycin

Labeler: aiping pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azithromycin dihydrate 200 mg/5mL

Manufacturer
AiPing Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11788-129
Product ID 11788-129_b4d8ea81-97cd-4aeb-a1a9-48e3f8587356
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217036
Listing Expiration 2027-12-31
Marketing Start 2026-01-16

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11788129
Hyphenated Format 11788-129

Supplemental Identifiers

RxCUI
141963 308459
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 ANDA217036 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (11788-129-13) / 15 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (11788-129-14) / 22.5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (11788-129-15) / 30 mL in 1 BOTTLE
source: ndc

Packages (3)

11788-129-13 1 BOTTLE in 1 CARTON (11788-129-13) / 15 mL in 1 BOTTLE 11788-129-14 1 BOTTLE in 1 CARTON (11788-129-14) / 22.5 mL in 1 BOTTLE 11788-129-15 1 BOTTLE in 1 CARTON (11788-129-15) / 30 mL in 1 BOTTLE

Ingredients (1)

azithromycin dihydrate (200 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": "b4d8ea81-97cd-4aeb-a1a9-48e3f8587356", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["141963", "308459"], "spl_set_id": ["d6fb42ed-7dac-4a7b-9964-d367dd47dd5c"], "manufacturer_name": ["AiPing Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (11788-129-13)  / 15 mL in 1 BOTTLE", "package_ndc": "11788-129-13", "marketing_start_date": "20260116"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (11788-129-14)  / 22.5 mL in 1 BOTTLE", "package_ndc": "11788-129-14", "marketing_start_date": "20260116"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (11788-129-15)  / 30 mL in 1 BOTTLE", "package_ndc": "11788-129-15", "marketing_start_date": "20260116"}], "brand_name": "Azithromycin", "product_id": "11788-129_b4d8ea81-97cd-4aeb-a1a9-48e3f8587356", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "11788-129", "generic_name": "Azithromycin", "labeler_name": "AiPing Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "200 mg/5mL"}], "application_number": "ANDA217036", "marketing_category": "ANDA", "marketing_start_date": "20260116", "listing_expiration_date": "20271231"}