hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen
Generic Name hydrocodone bitartrate and acetaminophen
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, hydrocodone bitartrate 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-116
Product ID 82804-116_9bad45b7-32ce-47aa-bfdf-8e6a75513056
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040409
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2000-10-20

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804116
Hyphenated Format 82804-116

Supplemental Identifiers

RxCUI
857002
UPC
0382804116126
UNII
362O9ITL9D NO70W886KK

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 hydrocodone bitartrate and acetaminophen (source: ndc)
Generic Name hydrocodone bitartrate and acetaminophen (source: ndc)
Application Number ANDA040409 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BOTTLE (82804-116-12)
source: ndc

Packages (1)

82804-116-12 12 TABLET in 1 BOTTLE (82804-116-12)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (5 mg/1)

Linked Drug Pages (1)

HYDROCODONE BITARTRATE AND ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9bad45b7-32ce-47aa-bfdf-8e6a75513056", "openfda": {"upc": ["0382804116126"], "unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857002"], "spl_set_id": ["9bad45b7-32ce-47aa-bfdf-8e6a75513056"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE (82804-116-12)", "package_ndc": "82804-116-12", "marketing_start_date": "20240702"}], "brand_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "product_id": "82804-116_9bad45b7-32ce-47aa-bfdf-8e6a75513056", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "82804-116", "dea_schedule": "CII", "generic_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA040409", "marketing_category": "ANDA", "marketing_start_date": "20001020", "listing_expiration_date": "20261231"}