hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: granules pharmaceuticals 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 granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-672
Product ID 70010-672_422263e3-1184-c7ea-e063-6294a90ae818
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211729
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-08-18

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010672
Hyphenated Format 70010-672

Supplemental Identifiers

RxCUI
856999 857002 857005
UPC
0370010673014 0370010674011 0370010672017
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 ANDA211729 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70010-672-01)
  • 500 TABLET in 1 BOTTLE (70010-672-05)
  • 1000 TABLET in 1 BOTTLE (70010-672-10)
source: ndc

Packages (3)

70010-672-01 100 TABLET in 1 BOTTLE (70010-672-01) 70010-672-05 500 TABLET in 1 BOTTLE (70010-672-05) 70010-672-10 1000 TABLET in 1 BOTTLE (70010-672-10)

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": "422263e3-1184-c7ea-e063-6294a90ae818", "openfda": {"upc": ["0370010673014", "0370010674011", "0370010672017"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["136bbd47-7a54-493f-9158-a84d39221d6c"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70010-672-01)", "package_ndc": "70010-672-01", "marketing_start_date": "20210818"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70010-672-05)", "package_ndc": "70010-672-05", "marketing_start_date": "20210818"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (70010-672-10)", "package_ndc": "70010-672-10", "marketing_start_date": "20250606"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "70010-672_422263e3-1184-c7ea-e063-6294a90ae818", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "70010-672", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Granules Pharmaceuticals 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": "ANDA211729", "marketing_category": "ANDA", "marketing_start_date": "20210818", "listing_expiration_date": "20261231"}