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 CAPSULE
Routes
ORAL
Active Ingredients

zidovudine 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-107
Product ID 65862-107_6da825d2-eacc-4a7d-98dc-7af924a9af92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078128
Listing Expiration 2026-12-31
Marketing Start 2006-03-27

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 65862107
Hyphenated Format 65862-107

Supplemental Identifiers

RxCUI
198352
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 ANDA078128 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (65862-107-01)
  • 10 BLISTER PACK in 1 CARTON (65862-107-10) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

65862-107-01 100 CAPSULE in 1 BOTTLE (65862-107-01) 65862-107-10 10 BLISTER PACK in 1 CARTON (65862-107-10) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

zidovudine (100 mg/1)

Linked Drug Pages (1)

Zidovudine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6da825d2-eacc-4a7d-98dc-7af924a9af92", "openfda": {"nui": ["N0000175462", "N0000009947"], "unii": ["4B9XT59T7S"], "rxcui": ["198352"], "spl_set_id": ["9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf"], "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": "100 CAPSULE in 1 BOTTLE (65862-107-01)", "package_ndc": "65862-107-01", "marketing_start_date": "20060327"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-107-10)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "65862-107-10", "marketing_start_date": "20060327"}], "brand_name": "Zidovudine", "product_id": "65862-107_6da825d2-eacc-4a7d-98dc-7af924a9af92", "dosage_form": "CAPSULE", "pharm_class": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "65862-107", "generic_name": "Zidovudine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zidovudine", "active_ingredients": [{"name": "ZIDOVUDINE", "strength": "100 mg/1"}], "application_number": "ANDA078128", "marketing_category": "ANDA", "marketing_start_date": "20060327", "listing_expiration_date": "20261231"}