zidovudine

Generic: zidovudine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zidovudine
Generic Name zidovudine
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zidovudine 300 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1613
Product ID 67046-1613_48c0ccac-2fe3-0fe2-e063-6294a90a2a9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090092
Listing Expiration 2027-12-31
Marketing Start 2025-11-13

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 670461613
Hyphenated Format 67046-1613

Supplemental Identifiers

RxCUI
199663
UNII
4B9XT59T7S
NUI
N0000175462 N0000009947

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 ANDA090092 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1613-3)
source: ndc

Packages (1)

67046-1613-3 30 TABLET in 1 BLISTER PACK (67046-1613-3)

Ingredients (1)

zidovudine (300 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": "48c0ccac-2fe3-0fe2-e063-6294a90a2a9c", "openfda": {"nui": ["N0000175462", "N0000009947"], "unii": ["4B9XT59T7S"], "rxcui": ["199663"], "spl_set_id": ["437f55b2-f6d9-0065-e063-6294a90ab929"], "pharm_class_epc": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1613-3)", "package_ndc": "67046-1613-3", "marketing_start_date": "20251113"}], "brand_name": "Zidovudine", "product_id": "67046-1613_48c0ccac-2fe3-0fe2-e063-6294a90a2a9c", "dosage_form": "TABLET", "pharm_class": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "67046-1613", "generic_name": "Zidovudine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zidovudine", "active_ingredients": [{"name": "ZIDOVUDINE", "strength": "300 mg/1"}], "application_number": "ANDA090092", "marketing_category": "ANDA", "marketing_start_date": "20251113", "listing_expiration_date": "20271231"}