hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: redpharm drug
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 redpharm drug
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2201
Product ID 67296-2201_4c1c4d8f-040e-4960-e063-6294a90afe65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210211
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2018-07-13

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672962201
Hyphenated Format 67296-2201

Supplemental Identifiers

RxCUI
857002
UPC
0371930019524 0371930020124 0371930021527 0371930021138 0371930020520 0371930021121 0371930020131 0371930019128
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 ANDA210211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE (67296-2201-1)
  • 6 TABLET in 1 BOTTLE (67296-2201-2)
  • 10 TABLET in 1 BOTTLE (67296-2201-3)
  • 15 TABLET in 1 BOTTLE (67296-2201-4)
  • 20 TABLET in 1 BOTTLE (67296-2201-5)
  • 30 TABLET in 1 BOTTLE (67296-2201-6)
  • 40 TABLET in 1 BOTTLE (67296-2201-7)
  • 12 TABLET in 1 BOTTLE (67296-2201-8)
source: ndc

Packages (8)

67296-2201-1 4 TABLET in 1 BOTTLE (67296-2201-1) 67296-2201-2 6 TABLET in 1 BOTTLE (67296-2201-2) 67296-2201-3 10 TABLET in 1 BOTTLE (67296-2201-3) 67296-2201-4 15 TABLET in 1 BOTTLE (67296-2201-4) 67296-2201-5 20 TABLET in 1 BOTTLE (67296-2201-5) 67296-2201-6 30 TABLET in 1 BOTTLE (67296-2201-6) 67296-2201-7 40 TABLET in 1 BOTTLE (67296-2201-7) 67296-2201-8 12 TABLET in 1 BOTTLE (67296-2201-8)

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": "4c1c4d8f-040e-4960-e063-6294a90afe65", "openfda": {"upc": ["0371930019524", "0371930020124", "0371930021527", "0371930021138", "0371930020520", "0371930021121", "0371930020131", "0371930019128"], "unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857002"], "spl_set_id": ["46c13d54-b181-4da2-e063-6294a90ab5c5"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE (67296-2201-1)", "package_ndc": "67296-2201-1", "marketing_start_date": "20180713"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (67296-2201-2)", "package_ndc": "67296-2201-2", "marketing_start_date": "20180713"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (67296-2201-3)", "package_ndc": "67296-2201-3", "marketing_start_date": "20180713"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (67296-2201-4)", "package_ndc": "67296-2201-4", "marketing_start_date": "20180713"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (67296-2201-5)", "package_ndc": "67296-2201-5", "marketing_start_date": "20180713"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67296-2201-6)", "package_ndc": "67296-2201-6", "marketing_start_date": "20180713"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (67296-2201-7)", "package_ndc": "67296-2201-7", "marketing_start_date": "20180713"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (67296-2201-8)", "package_ndc": "67296-2201-8", "marketing_start_date": "20180713"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "67296-2201_4c1c4d8f-040e-4960-e063-6294a90afe65", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "67296-2201", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Redpharm Drug", "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": "ANDA210211", "marketing_category": "ANDA", "marketing_start_date": "20180713", "listing_expiration_date": "20271231"}