oxaydo

Generic: oxycodone hydrochloride

Labeler: zyla life sciences us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaydo
Generic Name oxycodone hydrochloride
Labeler zyla life sciences us llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 7.5 mg/1

Manufacturer
Zyla Life Sciences US LLC

Identifiers & Regulatory

Product NDC 69344-213
Product ID 69344-213_5ab321c4-697f-4614-87bb-ec31a1429ef8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202080
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2015-09-01

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69344213
Hyphenated Format 69344-213

Supplemental Identifiers

RxCUI
1049621 1113314 1664448 1664634
UPC
0369344213119 0369344113112
UNII
C1ENJ2TE6C

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 oxaydo (source: ndc)
Generic Name oxycodone hydrochloride (source: ndc)
Application Number NDA202080 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69344-213-11)
source: ndc

Packages (1)

69344-213-11 100 TABLET in 1 BOTTLE (69344-213-11)

Ingredients (1)

oxycodone hydrochloride (7.5 mg/1)

Linked Drug Pages (1)

OXAYDO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5ab321c4-697f-4614-87bb-ec31a1429ef8", "openfda": {"upc": ["0369344213119", "0369344113112"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049621", "1113314", "1664448", "1664634"], "spl_set_id": ["cff0c64a-63f5-4b3c-909a-cdecf6755cbe"], "manufacturer_name": ["Zyla Life Sciences US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69344-213-11)", "package_ndc": "69344-213-11", "marketing_start_date": "20150901"}], "brand_name": "OXAYDO", "product_id": "69344-213_5ab321c4-697f-4614-87bb-ec31a1429ef8", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "69344-213", "dea_schedule": "CII", "generic_name": "OXYCODONE HYDROCHLORIDE", "labeler_name": "Zyla Life Sciences US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXAYDO", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "NDA202080", "marketing_category": "NDA", "marketing_start_date": "20150901", "listing_expiration_date": "20271231"}