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 TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

hydrocodone bitartrate 100 mg/1

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-397
Product ID 47781-397_271ec71a-ed16-53cb-f7a8-8d10949ec504
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208269
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-03-03

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47781397
Hyphenated Format 47781-397

Supplemental Identifiers

RxCUI
1595730 1595740 1595746 1595752 1595758 1595764 1595770
UPC
0347781394608 0347781397609 0347781395605 0347781398606 0347781392604 0347781396602 0347781393601
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 ANDA208269 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-397-60)
source: ndc

Packages (1)

47781-397-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-397-60)

Ingredients (1)

hydrocodone bitartrate (100 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": "271ec71a-ed16-53cb-f7a8-8d10949ec504", "openfda": {"upc": ["0347781394608", "0347781397609", "0347781395605", "0347781398606", "0347781392604", "0347781396602", "0347781393601"], "unii": ["NO70W886KK"], "rxcui": ["1595730", "1595740", "1595746", "1595752", "1595758", "1595764", "1595770"], "spl_set_id": ["f7b55d14-0980-b680-8ceb-7489ff65455e"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-397-60)", "package_ndc": "47781-397-60", "marketing_start_date": "20210303"}], "brand_name": "Hydrocodone Bitartrate", "product_id": "47781-397_271ec71a-ed16-53cb-f7a8-8d10949ec504", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "47781-397", "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": "100 mg/1"}], "application_number": "ANDA208269", "marketing_category": "ANDA", "marketing_start_date": "20210303", "listing_expiration_date": "20261231"}