HYDROCODONE BITARTRATE - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2016-07-14
Label type: Indexing - Product Concept
Version: 2
Source: full-release
Hydrated at: 2026-06-05 00:16:36

Label at a glance#

ProductHYDROCODONE BITARTRATE

Active ingredientHYDROCODONE BITARTRATE, IBUPROFEN

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

HYDROCODONE BITARTRATE
HYDROCODONE
IBUPROFEN

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROCODONE BITARTRATE	NO70W886KK	ACTIB
IBUPROFEN	WK2XYI10QM	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hysingla ER	HYDROCODONE BITARTRATE	Knoa Pharma LLC	b7d23ac2-e776-9f62-3290-c64c2d6eb353	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROCODONE BITARTRATE
Hydrocodone Bitartrate	HYDROCODONE BITARTRATE	Alvogen Inc.	f7b55d14-0980-b680-8ceb-7489ff65455e	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydrocodone Bitartrate generic name: HYDROCODONE BITARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.