hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: specgx llc
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 specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, hydrocodone bitartrate 10 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0125
Product ID 0406-0125_7fc74fc4-ad92-4324-bc17-66d6c3e31808
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040400
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2000-07-26

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04060125
Hyphenated Format 0406-0125

Supplemental Identifiers

RxCUI
856999 857002 857005
UPC
0304060124011 0304060125018 0304060123014
UNII
NO70W886KK 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 hydrocodone bitartrate and acetaminophen (source: ndc)
Generic Name hydrocodone bitartrate and acetaminophen (source: ndc)
Application Number ANDA040400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-0125-01)
  • 500 TABLET in 1 BOTTLE (0406-0125-05)
  • 1000 TABLET in 1 BOTTLE (0406-0125-10)
  • 120 TABLET in 1 BOTTLE (0406-0125-12)
  • 20 TABLET in 1 BOTTLE (0406-0125-20)
  • 1 TABLET in 1 BLISTER PACK (0406-0125-23)
  • 30 TABLET in 1 BOTTLE (0406-0125-30)
  • 60 TABLET in 1 BOTTLE (0406-0125-60)
  • 100 TABLET in 1 BLISTER PACK (0406-0125-62)
  • 90 TABLET in 1 BOTTLE (0406-0125-90)
source: ndc

Packages (10)

0406-0125-01 100 TABLET in 1 BOTTLE (0406-0125-01) 0406-0125-05 500 TABLET in 1 BOTTLE (0406-0125-05) 0406-0125-10 1000 TABLET in 1 BOTTLE (0406-0125-10) 0406-0125-12 120 TABLET in 1 BOTTLE (0406-0125-12) 0406-0125-20 20 TABLET in 1 BOTTLE (0406-0125-20) 0406-0125-23 1 TABLET in 1 BLISTER PACK (0406-0125-23) 0406-0125-30 30 TABLET in 1 BOTTLE (0406-0125-30) 0406-0125-60 60 TABLET in 1 BOTTLE (0406-0125-60) 0406-0125-62 100 TABLET in 1 BLISTER PACK (0406-0125-62) 0406-0125-90 90 TABLET in 1 BOTTLE (0406-0125-90)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (10 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": "7fc74fc4-ad92-4324-bc17-66d6c3e31808", "openfda": {"upc": ["0304060124011", "0304060125018", "0304060123014"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["73c1059b-0c7d-42ef-9827-f018858fc447"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-0125-01)", "package_ndc": "0406-0125-01", "marketing_start_date": "20000726"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0406-0125-05)", "package_ndc": "0406-0125-05", "marketing_start_date": "20000726"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0406-0125-10)", "package_ndc": "0406-0125-10", "marketing_start_date": "20000726"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (0406-0125-12)", "package_ndc": "0406-0125-12", "marketing_start_date": "20000726"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (0406-0125-20)", "package_ndc": "0406-0125-20", "marketing_start_date": "20000726"}, {"sample": false, "description": "1 TABLET in 1 BLISTER PACK (0406-0125-23)", "package_ndc": "0406-0125-23", "marketing_start_date": "20000726"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (0406-0125-30)", "package_ndc": "0406-0125-30", "marketing_start_date": "20000726"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (0406-0125-60)", "package_ndc": "0406-0125-60", "marketing_start_date": "20000726"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (0406-0125-62)", "package_ndc": "0406-0125-62", "marketing_start_date": "20000726"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0406-0125-90)", "package_ndc": "0406-0125-90", "marketing_start_date": "20000726"}], "brand_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "product_id": "0406-0125_7fc74fc4-ad92-4324-bc17-66d6c3e31808", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0406-0125", "dea_schedule": "CII", "generic_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA040400", "marketing_category": "ANDA", "marketing_start_date": "20000726", "listing_expiration_date": "20261231"}