hydrocodone bitartrate

Generic: hydrocodone bitartrate

Labeler: alvogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate
Generic Name hydrocodone bitartrate
Labeler alvogen inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

hydrocodone bitartrate 50 mg/1

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-414
Product ID 47781-414_efb4a6cd-a407-a935-70b9-6ab1074ca819
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206986
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-01-21

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47781414
Hyphenated Format 47781-414

Supplemental Identifiers

RxCUI
1860491 1860493 1860495 1860497 1860499 1860501
UPC
0347781412609 0347781411602 0347781410605 0347781413606 0347781409609 0347781414603
UNII
NO70W886KK

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 (source: ndc)
Generic Name hydrocodone bitartrate (source: ndc)
Application Number ANDA206986 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-414-60)
source: ndc

Packages (1)

47781-414-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-414-60)

Ingredients (1)

hydrocodone bitartrate (50 mg/1)

Linked Drug Pages (1)

Hydrocodone Bitartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "efb4a6cd-a407-a935-70b9-6ab1074ca819", "openfda": {"upc": ["0347781412609", "0347781411602", "0347781410605", "0347781413606", "0347781409609", "0347781414603"], "unii": ["NO70W886KK"], "rxcui": ["1860491", "1860493", "1860495", "1860497", "1860499", "1860501"], "spl_set_id": ["a7b8ea07-e926-f0a5-c20d-92f23ed350d0"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-414-60)", "package_ndc": "47781-414-60", "marketing_start_date": "20200121"}], "brand_name": "Hydrocodone Bitartrate", "product_id": "47781-414_efb4a6cd-a407-a935-70b9-6ab1074ca819", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "47781-414", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate", "active_ingredients": [{"name": "HYDROCODONE BITARTRATE", "strength": "50 mg/1"}], "application_number": "ANDA206986", "marketing_category": "ANDA", "marketing_start_date": "20200121", "listing_expiration_date": "20261231"}