hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: kvk-tech, inc.
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 kvk-tech, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-189
Product ID 10702-189_4a169a07-a8cd-ada4-e063-6394a90ac7d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209037
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2017-06-22

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10702189
Hyphenated Format 10702-189

Supplemental Identifiers

RxCUI
856980 856987 856992 856999 857002 857005
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 ANDA209037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10702-189-01)
  • 30 TABLET in 1 BOTTLE (10702-189-03)
  • 1000 TABLET in 1 BOTTLE (10702-189-10)
  • 500 TABLET in 1 BOTTLE (10702-189-50)
source: ndc

Packages (4)

10702-189-01 100 TABLET in 1 BOTTLE (10702-189-01) 10702-189-03 30 TABLET in 1 BOTTLE (10702-189-03) 10702-189-10 1000 TABLET in 1 BOTTLE (10702-189-10) 10702-189-50 500 TABLET in 1 BOTTLE (10702-189-50)

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": "4a169a07-a8cd-ada4-e063-6394a90ac7d2", "openfda": {"unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856980", "856987", "856992", "856999", "857002", "857005"], "spl_set_id": ["f1063950-b302-4898-81c2-b1626c9c16ef"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10702-189-01)", "package_ndc": "10702-189-01", "marketing_start_date": "20170622"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (10702-189-03)", "package_ndc": "10702-189-03", "marketing_start_date": "20170622"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (10702-189-10)", "package_ndc": "10702-189-10", "marketing_start_date": "20170622"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (10702-189-50)", "package_ndc": "10702-189-50", "marketing_start_date": "20170622"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "10702-189_4a169a07-a8cd-ada4-e063-6394a90ac7d2", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "10702-189", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "KVK-Tech, Inc.", "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": "ANDA209037", "marketing_category": "ANDA", "marketing_start_date": "20170622", "listing_expiration_date": "20271231"}