hydrocodone bitartrate and acetaminophen (42858-203)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler rhodes pharmaceuticals l.p.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-203

Product ID 42858-203_121d5573-efb2-4cc3-8a1e-9dd7adfee4d3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202991

DEA Schedule cii

Listing Expiration 2027-12-31

Marketing Start 2016-04-12

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858203

Hyphenated Format 42858-203

Supplemental Identifiers

RxCUI

856999 857002 857005

UPC

0342858202015 0342858201018 0342858203012

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 ANDA202991 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (42858-203-01)
100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-203-10) / 1 TABLET in 1 BLISTER PACK
500 TABLET in 1 BOTTLE (42858-203-50)
1000 TABLET in 1 BOTTLE (42858-203-90)

source: ndc

Packages (4)

42858-203-01 100 TABLET in 1 BOTTLE (42858-203-01) 42858-203-10 100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-203-10) / 1 TABLET in 1 BLISTER PACK 42858-203-50 500 TABLET in 1 BOTTLE (42858-203-50) 42858-203-90 1000 TABLET in 1 BOTTLE (42858-203-90)

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": "121d5573-efb2-4cc3-8a1e-9dd7adfee4d3", "openfda": {"upc": ["0342858202015", "0342858201018", "0342858203012"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["1f9c1adc-f84f-43de-af5c-d93703aba7f8"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42858-203-01)", "package_ndc": "42858-203-01", "marketing_start_date": "20160412"}, {"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-203-10)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "42858-203-10", "marketing_start_date": "20160412"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42858-203-50)", "package_ndc": "42858-203-50", "marketing_start_date": "20160412"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42858-203-90)", "package_ndc": "42858-203-90", "marketing_start_date": "20160412"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "42858-203_121d5573-efb2-4cc3-8a1e-9dd7adfee4d3", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "42858-203", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Rhodes Pharmaceuticals L.P.", "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": "ANDA202991", "marketing_category": "ANDA", "marketing_start_date": "20160412", "listing_expiration_date": "20271231"}