methadone hydrochloride

Generic: methadone hydrochloride

Labeler: aurolife pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler aurolife pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methadone hydrochloride 5 mg/1

Manufacturer
Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-088
Product ID 13107-088_73006026-6ba2-49da-824e-a4d05b99a2e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203502
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-09-15

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107088
Hyphenated Format 13107-088

Supplemental Identifiers

RxCUI
864706 864718
UPC
0313107089015 0313107088018
UNII
229809935B

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 methadone hydrochloride (source: ndc)
Generic Name methadone hydrochloride (source: ndc)
Application Number ANDA203502 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-088-01)
  • 30 TABLET in 1 BOTTLE (13107-088-30)
  • 1000 TABLET in 1 BOTTLE (13107-088-99)
source: ndc

Packages (3)

13107-088-01 100 TABLET in 1 BOTTLE (13107-088-01) 13107-088-30 30 TABLET in 1 BOTTLE (13107-088-30) 13107-088-99 1000 TABLET in 1 BOTTLE (13107-088-99)

Ingredients (1)

methadone hydrochloride (5 mg/1)

Linked Drug Pages (1)

Methadone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "73006026-6ba2-49da-824e-a4d05b99a2e7", "openfda": {"upc": ["0313107089015", "0313107088018"], "unii": ["229809935B"], "rxcui": ["864706", "864718"], "spl_set_id": ["6984eb5a-57a3-4686-bc67-91bc3e7a531e"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-088-01)", "package_ndc": "13107-088-01", "marketing_start_date": "20150915"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13107-088-30)", "package_ndc": "13107-088-30", "marketing_start_date": "20150915"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-088-99)", "package_ndc": "13107-088-99", "marketing_start_date": "20150915"}], "brand_name": "Methadone Hydrochloride", "product_id": "13107-088_73006026-6ba2-49da-824e-a4d05b99a2e7", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13107-088", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203502", "marketing_category": "ANDA", "marketing_start_date": "20150915", "listing_expiration_date": "20261231"}