FDA.reportPublic FDA data

NDC 58177-449 - Hydromorphone Hydrochloride

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
58177-449
Package NDCs from labels
58177-449-04, 58177-449-09, 58177-449-11
Manufacturer
ETHEX Corporation
Effective date
2007-01-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydromorphone Hydrochloride - ETHEX CorporationETHEX Corporation2007-01-10Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-449-04Hydromorphone Hydrochloride100 in 1 BOTTLETABLET1001
58177-449-09Hydromorphone Hydrochloride1000 in 1 BOTTLETABLET10001
58177-449-11Hydromorphone Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-449HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]13 package rows20080313_78353952-324c-4a8d-818c-6537fca21d4e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydromorphone hydrochlorideACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
HydromorphoneACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
colloidal silicon dioxideINACTIVE INGREDIENTHYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
FD&C Blue No. 1 aluminum lakeINACTIVE INGREDIENTHYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
FD&C Red No. 40 aluminum lakeINACTIVE INGREDIENTHYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
FD&C Yellow No. 6 aluminum lakeINACTIVE INGREDIENTHYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
lactose hydrousINACTIVE INGREDIENTHYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
magnesium stearateINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
microcrystalline celluloseINACTIVE INGREDIENTHYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [ETHEX CORPORATION]1
sodium starch glycolateINACTIVE INGREDIENTHYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) TABLET [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 ยท 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDERedpharm Drug59d88866-e1ba-9d97-e063-6394a90a7b272026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESpecGx LLC4c5c1cc8-c42b-46e3-ad68-8e22f57101f22026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897710
rxcui: 897702
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack2427814c-f32b-8ac5-99b8-5e886fd2d0012026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy53ddcacc-99e4-8b21-e063-6394a90a3e792026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897702
DilaudidHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLCd6b40e39-a57e-402c-b4f6-7041e832f8372026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897710
rxcui: 897702
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLC37565441-0d95-4743-a695-d7b3326f58a12026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897710
rxcui: 897702
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897702
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packaginge4758743-9b2c-4612-8399-ad2db372e2b72026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897702
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.cc574063-6ede-4da7-82c4-7450c92b229b2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897710
rxcui: 897702
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEASCLEMED USA INC.18f6f54e-1537-4181-9d07-54ddf881a9ee2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897710
rxcui: 897702
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEAscent Pharmaceuticals Inc4de15afe-d676-4faa-a34d-9b9cb20dbf542024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897710
rxcui: 897702
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack29765ff0-3b1d-47da-953e-28bf0e6a56ef2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897702
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEAurolife Pharma, LLCf778dfab-e109-428e-b1b7-4dfb1b8293e42023-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897710
rxcui: 897702
4D2291E1-453A-5C5D-DFA5-3BC5884E49AF78353952-324c-4a8d-818c-6537fca21d4e2007-01-10Warnings, Adverse reactionsExact identifier
spl id: 4D2291E1-453A-5C5D-DFA5-3BC5884E49AF
spl set id: 78353952-324c-4a8d-818c-6537fca21d4e

Reported adverse events (FAERS/openFDA)#

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