hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: aurolife pharma, llc
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 aurolife pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, hydrocodone bitartrate 7.5 mg/1

Manufacturer
Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-212
Product ID 13107-212_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 13107212
Hyphenated Format 13107-212

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
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-212-01)
  • 500 TABLET in 1 BOTTLE (13107-212-05)
  • 30 TABLET in 1 BOTTLE (13107-212-30)
  • 1000 TABLET in 1 BOTTLE (13107-212-99)
source: ndc

Packages (4)

13107-212-01 100 TABLET in 1 BOTTLE (13107-212-01) 13107-212-05 500 TABLET in 1 BOTTLE (13107-212-05) 13107-212-30 30 TABLET in 1 BOTTLE (13107-212-30) 13107-212-99 1000 TABLET in 1 BOTTLE (13107-212-99)

Ingredients (2)

acetaminophen (300 mg/1) hydrocodone bitartrate (7.5 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": "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 (13107-212-01)", "package_ndc": "13107-212-01", "marketing_start_date": "20150506"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13107-212-05)", "package_ndc": "13107-212-05", "marketing_start_date": "20150506"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13107-212-30)", "package_ndc": "13107-212-30", "marketing_start_date": "20150506"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-212-99)", "package_ndc": "13107-212-99", "marketing_start_date": "20150506"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "13107-212_265ff2e7-c060-4a82-909b-26e71c262dd6", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "13107-212", "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": "7.5 mg/1"}], "application_number": "ANDA207709", "marketing_category": "ANDA", "marketing_start_date": "20150506", "listing_expiration_date": "20261231"}