roxybond

Generic: oxycodone hydrochloride

Labeler: protega pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name roxybond
Generic Name oxycodone hydrochloride
Labeler protega pharmaceuticals inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 10 mg/1

Manufacturer
Protega Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 81140-104
Product ID 81140-104_484b1240-1832-049e-e063-6394a90aaa6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209777
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2017-04-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81140104
Hyphenated Format 81140-104

Supplemental Identifiers

RxCUI
1944529 1944535 1944538 1944540 1944541 1944543 2693194 2693196
UPC
0381140104101 0381140102107 0381140101100 0381140103104
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 roxybond (source: ndc)
Generic Name oxycodone hydrochloride (source: ndc)
Application Number NDA209777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (81140-104-10)
source: ndc

Packages (1)

81140-104-10 100 TABLET, COATED in 1 BOTTLE (81140-104-10)

Ingredients (1)

oxycodone hydrochloride (10 mg/1)

Linked Drug Pages (1)

RoxyBond ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "484b1240-1832-049e-e063-6394a90aaa6a", "openfda": {"upc": ["0381140104101", "0381140102107", "0381140101100", "0381140103104"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1944529", "1944535", "1944538", "1944540", "1944541", "1944543", "2693194", "2693196"], "spl_set_id": ["72398542-8e0a-47b2-afeb-9ca5a1f15083"], "manufacturer_name": ["Protega Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (81140-104-10)", "package_ndc": "81140-104-10", "marketing_start_date": "20231219"}], "brand_name": "RoxyBond", "product_id": "81140-104_484b1240-1832-049e-e063-6394a90aaa6a", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "81140-104", "dea_schedule": "CII", "generic_name": "Oxycodone hydrochloride", "labeler_name": "Protega Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RoxyBond", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA209777", "marketing_category": "NDA", "marketing_start_date": "20170420", "listing_expiration_date": "20271231"}