hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: rhodes pharmaceuticals l.p.
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 rhodes pharmaceuticals l.p.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-201
Product ID 42858-201_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 42858201
Hyphenated Format 42858-201

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
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42858-201-01)
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-201-10) / 1 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (42858-201-50)
source: ndc

Packages (3)

42858-201-01 100 TABLET in 1 BOTTLE (42858-201-01) 42858-201-10 100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-201-10) / 1 TABLET in 1 BLISTER PACK 42858-201-50 500 TABLET in 1 BOTTLE (42858-201-50)

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": "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 (42858-201-01)", "package_ndc": "42858-201-01", "marketing_start_date": "20160412"}, {"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-201-10)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "42858-201-10", "marketing_start_date": "20160412"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42858-201-50)", "package_ndc": "42858-201-50", "marketing_start_date": "20160412"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "42858-201_121d5573-efb2-4cc3-8a1e-9dd7adfee4d3", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "42858-201", "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": "5 mg/1"}], "application_number": "ANDA202991", "marketing_category": "ANDA", "marketing_start_date": "20160412", "listing_expiration_date": "20271231"}