NDC 58177-909-07 - Hydrocodone Bitartrate and Acetaminophen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58177-909
Requested NDC
58177-909-07
Package NDCs from labels
58177-909-07
Manufacturer
ETHEX Corporation
Effective date
2007-03-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocodone Bitartrate and Acetaminophen - ETHEX CorporationETHEX Corporation2007-03-12Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-909-07Hydrocodone Bitartrate and Acetaminophen473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-909HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]11 package rows20080313_6222b0cf-7222-41c3-bdfc-5f799a8ef394.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
acetaminophenACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
Hydrocodone bitartrateACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
acetaminophenACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
hydrocodoneACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
ammoniated glyyerrhizinINACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
citric acidINACTIVE INGREDIENT2968PHW8QPHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
D&C Yellow No. 10INACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
dibasic sodium phosphateINACTIVE INGREDIENTGR686LBA74HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
ethyl maltolINACTIVE INGREDIENTL6Q8K29L05HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
FD&C Yellow No. 6INACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
Natural and artifical flavoringINACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
polyethylene glycolINACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
sodium gluconateINACTIVE INGREDIENTR6Q3791S76HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
sorbitol solutionINACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1
waterINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) LIQUID [ETHEX CORPORATION]1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A37E838C-9DC0-D426-2E27-6FCF3A0414236222b0cf-7222-41c3-bdfc-5f799a8ef3942007-03-12Warnings, Adverse reactionsExact identifier
spl id: A37E838C-9DC0-D426-2E27-6FCF3A041423
spl set id: 6222b0cf-7222-41c3-bdfc-5f799a8ef394

Reported adverse events (FAERS/openFDA)#

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