hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: elite laboratories, 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 elite laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-631
Product ID 64850-631_91acad07-a9ce-450e-b9f6-4401b89bd32c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209924
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-11-16

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64850631
Hyphenated Format 64850-631

Supplemental Identifiers

RxCUI
856999 857002 857005 857391
UPC
0364850630016 0364850633017 0364850632010 0364850631013
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 ANDA209924 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (64850-631-01)
source: ndc

Packages (1)

64850-631-01 100 TABLET in 1 BOTTLE, PLASTIC (64850-631-01)

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": "91acad07-a9ce-450e-b9f6-4401b89bd32c", "openfda": {"upc": ["0364850630016", "0364850633017", "0364850632010", "0364850631013"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005", "857391"], "spl_set_id": ["89b8145f-5310-4b58-a65d-586dc90d642d"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64850-631-01)", "package_ndc": "64850-631-01", "marketing_start_date": "20181116"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "64850-631_91acad07-a9ce-450e-b9f6-4401b89bd32c", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "64850-631", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Elite Laboratories, 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": "ANDA209924", "marketing_category": "ANDA", "marketing_start_date": "20181116", "listing_expiration_date": "20261231"}