oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler rhodes pharmaceuticals l.p.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 5 mg/1

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-001
Product ID 42858-001_f1c3bf11-f460-43bf-9593-ed80fadcd317
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091490
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2014-09-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858001
Hyphenated Format 42858-001

Supplemental Identifiers

RxCUI
1049611 1049618 1049621 1049683 1049686
UPC
0342858002011 0342858004015
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 ANDA091490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (42858-001-01)
  • 10 BLISTER PACK in 1 CARTON (42858-001-10) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

42858-001-01 100 TABLET in 1 BOTTLE, PLASTIC (42858-001-01) 42858-001-10 10 BLISTER PACK in 1 CARTON (42858-001-10) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

oxycodone hydrochloride (5 mg/1)

Linked Drug Pages (1)

Oxycodone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f1c3bf11-f460-43bf-9593-ed80fadcd317", "openfda": {"upc": ["0342858002011", "0342858004015"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049611", "1049618", "1049621", "1049683", "1049686"], "spl_set_id": ["a5162476-1217-41c0-bc7e-0a0f123f069f"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (42858-001-01)", "package_ndc": "42858-001-01", "marketing_start_date": "20140908"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42858-001-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "42858-001-10", "marketing_start_date": "20140908"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "42858-001_f1c3bf11-f460-43bf-9593-ed80fadcd317", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "42858-001", "dea_schedule": "CII", "generic_name": "Oxycodone Hydrochloride", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA091490", "marketing_category": "ANDA", "marketing_start_date": "20140908", "listing_expiration_date": "20271231"}