FDA.reportPublic FDA data

homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution

RxCUI
992668
RxNorm name
homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution
Display name
homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution
Full name
homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:11

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTIONKVK-Tech, Inc.9a737416-08e0-4df6-897e-cf9d1b5f0b012026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992668
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGenus Lifesciences Inc.320ff639-9854-407b-9bbd-a035c4f173e12026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992668
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEPAI Holdings, LLC dba PAI Pharma71319a6f-aaf4-4bc5-8b40-a16c6f139be62026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992668
HydrometHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEActavis Pharma, Inc.a324c912-a3ef-4296-b9a8-b0fec687eb062026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992668
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDENovel Laboratories, Inc.4050ae05-7f1a-48b7-99b9-f8db8aa027412024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992668

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 11 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a324c912-a3ef-4296-b9a8-b0fec687eb06HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]328These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION . H Y D ROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution, CII Initial U.S. Approval: 194320260201
7d45e534-338b-4c98-b85f-edd19a287e14HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]321These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION. HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution, CII Initial U.S. Approval: 194320220311
9a737416-08e0-4df6-897e-cf9d1b5f0b01HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]313These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE. HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution, CII Initial U.S. Approval: 194320260522
4050ae05-7f1a-48b7-99b9-f8db8aa02741HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]38These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION (Syrup) safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION (Syrup) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution (syrup) for oral administration, CII Initial U.S. Approval: 194320241008
8d4a9c18-f9e8-4474-8c76-7378bcdcacb6HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]38These highlights do not include all the information needed to use hydrocodone bitartrate and homatropine methylbromide oral solution safely and effectively. See full prescribing information for hydrocodone bitartrate and homatropine methylbromide oral solution. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, for oral administration, CII Initial U.S. Approval: 194320190116
0184de92-e728-4390-95f6-a463f583416aHYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]33Hydrocodone Bitartrate and Homatropine Methylbromide Syrup20111215
320ff639-9854-407b-9bbd-a035c4f173e1HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]32These highlights do not include all the information needed to use hydrocodone bitartrate and homatropine methylbromide safely and effectively. See full prescribing information for hydrocodone bitartrate and homatropine methylbromide. Hydrocodone bitartrate and homatropine methylbromide tablets, for oral use, CII Hydrocodone bitartrate and homatropine methylbromide oral solution, CII Initial U.S. Approval: 194320260507
0f06291e-6329-4eb0-8cb7-80a14111d480HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]32HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP20160301
71319a6f-aaf4-4bc5-8b40-a16c6f139be6HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]31These highlights do not include all the information needed to use hydrocodone bitartrate and homatropine methylbromide safely and effectively. See full prescribing information for hydrocodone bitartrate and homatropine methylbromide. Hydrocodone bitartrate and homatropine methylbromide oral solution, CII Initial U.S. Approval: 194320240805
363701bc-1d0b-4cd0-a3a6-e0c3c849013aHYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]31These highlights do not include all the information needed to use Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution safely and effectively. See full prescribing information for Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution. Initial U.S. Approval: 194320210407
95828fad-323e-4510-acbf-6d354b25b887HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution [PSN] · homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [SCD] · homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup [SY]31Hydrocodone Bitartrate and Homatropine Methylbromide Syrup20110104