hydrocodone bitartrate and acetaminophen (13107-213)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler aurolife pharma, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, hydrocodone bitartrate 10 mg/1

Manufacturer

Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-213

Product ID 13107-213_265ff2e7-c060-4a82-909b-26e71c262dd6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207709

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2015-05-06

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107213

Hyphenated Format 13107-213

Supplemental Identifiers

RxCUI

856980 856987 856992

UPC

0313107213014 0313107211010

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 ANDA207709 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (13107-213-01)
500 TABLET in 1 BOTTLE (13107-213-05)
30 TABLET in 1 BOTTLE (13107-213-30)
1000 TABLET in 1 BOTTLE (13107-213-99)

source: ndc

Packages (4)

13107-213-01 100 TABLET in 1 BOTTLE (13107-213-01) 13107-213-05 500 TABLET in 1 BOTTLE (13107-213-05) 13107-213-30 30 TABLET in 1 BOTTLE (13107-213-30) 13107-213-99 1000 TABLET in 1 BOTTLE (13107-213-99)

Ingredients (2)

acetaminophen (300 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": "265ff2e7-c060-4a82-909b-26e71c262dd6", "openfda": {"upc": ["0313107213014", "0313107211010"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856980", "856987", "856992"], "spl_set_id": ["392a846e-7325-462d-b19b-8afda44c5cb0"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-213-01)", "package_ndc": "13107-213-01", "marketing_start_date": "20150506"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13107-213-05)", "package_ndc": "13107-213-05", "marketing_start_date": "20150506"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13107-213-30)", "package_ndc": "13107-213-30", "marketing_start_date": "20150506"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-213-99)", "package_ndc": "13107-213-99", "marketing_start_date": "20150506"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "13107-213_265ff2e7-c060-4a82-909b-26e71c262dd6", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "13107-213", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA207709", "marketing_category": "ANDA", "marketing_start_date": "20150506", "listing_expiration_date": "20261231"}