zidovudine

Generic: zidovudine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zidovudine
Generic Name zidovudine
Labeler aurobindo pharma limited
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

zidovudine 10 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-048
Product ID 65862-048_19584bb3-e849-4839-961f-c38bb07a4e8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077268
Listing Expiration 2026-12-31
Marketing Start 2005-09-19

Pharmacologic Class

Established (EPC)
human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862048
Hyphenated Format 65862-048

Supplemental Identifiers

RxCUI
756209
UPC
0365862048240
UNII
4B9XT59T7S
NUI
N0000175462 N0000009947

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 zidovudine (source: ndc)
Generic Name zidovudine (source: ndc)
Application Number ANDA077268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE (65862-048-24)
source: ndc

Packages (1)

65862-048-24 240 mL in 1 BOTTLE (65862-048-24)

Ingredients (1)

zidovudine (10 mg/mL)

Linked Drug Pages (1)

Zidovudine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19584bb3-e849-4839-961f-c38bb07a4e8c", "openfda": {"nui": ["N0000175462", "N0000009947"], "upc": ["0365862048240"], "unii": ["4B9XT59T7S"], "rxcui": ["756209"], "spl_set_id": ["51abd2ce-6be1-412d-b806-5f24935ac5e3"], "pharm_class_epc": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE (65862-048-24)", "package_ndc": "65862-048-24", "marketing_start_date": "20050919"}], "brand_name": "Zidovudine", "product_id": "65862-048_19584bb3-e849-4839-961f-c38bb07a4e8c", "dosage_form": "SYRUP", "pharm_class": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "65862-048", "generic_name": "Zidovudine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zidovudine", "active_ingredients": [{"name": "ZIDOVUDINE", "strength": "10 mg/mL"}], "application_number": "ANDA077268", "marketing_category": "ANDA", "marketing_start_date": "20050919", "listing_expiration_date": "20261231"}