oxycodone and acetaminophen

Generic: oxycodone hydrochloride and acetaminophen

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

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone hydrochloride and acetaminophen
Labeler specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, oxycodone hydrochloride 5 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0512
Product ID 0406-0512_38cc2423-8e75-4007-b224-75aa920582d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087463
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 1983-12-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04060512
Hyphenated Format 0406-0512

Supplemental Identifiers

RxCUI
1049214 1049221 1049225
UPC
0304060522053 0304060523050 0304060512054
UNII
C1ENJ2TE6C 362O9ITL9D

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 and acetaminophen (source: ndc)
Generic Name oxycodone hydrochloride and acetaminophen (source: ndc)
Application Number ANDA087463 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-0512-01)
  • 500 TABLET in 1 BOTTLE (0406-0512-05)
  • 1 TABLET in 1 BLISTER PACK (0406-0512-23)
  • 100 TABLET in 1 BLISTER PACK (0406-0512-62)
  • 5000 TABLET in 1 PAIL (0406-0512-91)
source: ndc

Packages (5)

0406-0512-01 100 TABLET in 1 BOTTLE (0406-0512-01) 0406-0512-05 500 TABLET in 1 BOTTLE (0406-0512-05) 0406-0512-23 1 TABLET in 1 BLISTER PACK (0406-0512-23) 0406-0512-62 100 TABLET in 1 BLISTER PACK (0406-0512-62) 0406-0512-91 5000 TABLET in 1 PAIL (0406-0512-91)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (5 mg/1)

Linked Drug Pages (1)

OXYCODONE AND ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38cc2423-8e75-4007-b224-75aa920582d7", "openfda": {"upc": ["0304060522053", "0304060523050", "0304060512054"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225"], "spl_set_id": ["f2137f1a-b49a-40bd-97ac-cd6b36e295f4"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-0512-01)", "package_ndc": "0406-0512-01", "marketing_start_date": "19831207"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0406-0512-05)", "package_ndc": "0406-0512-05", "marketing_start_date": "19831207"}, {"sample": false, "description": "1 TABLET in 1 BLISTER PACK (0406-0512-23)", "package_ndc": "0406-0512-23", "marketing_start_date": "19831207"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (0406-0512-62)", "package_ndc": "0406-0512-62", "marketing_start_date": "19831207"}, {"sample": false, "description": "5000 TABLET in 1 PAIL (0406-0512-91)", "package_ndc": "0406-0512-91", "marketing_start_date": "19831207"}], "brand_name": "OXYCODONE AND ACETAMINOPHEN", "product_id": "0406-0512_38cc2423-8e75-4007-b224-75aa920582d7", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-0512", "dea_schedule": "CII", "generic_name": "oxycodone hydrochloride and acetaminophen", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYCODONE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA087463", "marketing_category": "ANDA", "marketing_start_date": "19831207", "listing_expiration_date": "20271231"}