oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 5 mg/5mL

Manufacturer
MAJOR PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 0904-6828
Product ID 0904-6828_f661966e-fbda-4dbb-85de-b31056fc7032
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207511
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2016-11-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046828
Hyphenated Format 0904-6828

Supplemental Identifiers

RxCUI
1049604
UPC
0309046828921
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 oxycodone hydrochloride (source: ndc)
Generic Name oxycodone hydrochloride (source: ndc)
Application Number ANDA207511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 5 TRAY in 1 CARTON (0904-6828-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05)
  • 4 TRAY in 1 CARTON (0904-6828-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05)
source: ndc

Packages (2)

0904-6828-92 5 TRAY in 1 CARTON (0904-6828-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05) 0904-6828-94 4 TRAY in 1 CARTON (0904-6828-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05)

Ingredients (1)

oxycodone hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Oxycodone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f661966e-fbda-4dbb-85de-b31056fc7032", "openfda": {"upc": ["0309046828921"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049604"], "spl_set_id": ["6d249bc5-79c4-4c42-a71b-d667c75163db"], "manufacturer_name": ["MAJOR PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 TRAY in 1 CARTON (0904-6828-92)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05)", "package_ndc": "0904-6828-92", "marketing_start_date": "20161123"}, {"sample": false, "description": "4 TRAY in 1 CARTON (0904-6828-94)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05)", "package_ndc": "0904-6828-94", "marketing_start_date": "20161123"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "0904-6828_f661966e-fbda-4dbb-85de-b31056fc7032", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0904-6828", "dea_schedule": "CII", "generic_name": "Oxycodone Hydrochloride", "labeler_name": "MAJOR PHARMACEUTICALS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA207511", "marketing_category": "ANDA", "marketing_start_date": "20161123", "listing_expiration_date": "20271231"}