FDA.reportPublic FDA data

NDC 0409-2634-10 - 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
0409-2634
Requested NDC
0409-2634-10
Package NDCs from labels
0409-2634-10, 0409-2634-01, 0409-2634-25, 0409-2634-05, 0409-2634-50
Manufacturer
Hospira, Inc.
Effective date
2026-04-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydromorphone Hydrochloride - Hospira, Inc.Hospira, Inc.2026-04-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2634-01Hydromorphone Hydrochloride10 in 1 BOXINJECTION, SOLUTION1025
0409-2634-05Hydromorphone Hydrochloride10 in 1 BOXINJECTION, SOLUTION1025
0409-2634-10Hydromorphone Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION125
0409-2634-25Hydromorphone Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION525
0409-2634-50Hydromorphone Hydrochloride1 in 1 BOXINJECTION, SOLUTION125
0409-2634-50Hydromorphone Hydrochloride50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2634HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]24Current NDC, Legacy NDC, 6 package rows20250508_3832ede8-d3fc-455d-ecab-3b77be5869f5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2634-01ML - Milliliter0409-2634b7377bdd-1824-4f21-a656-504cb1608fd412012-07-24
0409-2634-05ML - Milliliter0409-2634b7231e2f-35ef-4ce1-91c4-545811e5fdad12012-07-24
0409-2634-10ML - Milliliter0409-2634cdcd3427-6adc-4e47-b157-bd6a12714ba612020-07-13
0409-2634-25ML - Milliliter0409-26349c74d04e-e0ae-49c9-a5a0-30f5166c6c3712020-07-13
0409-2634-50ML - Milliliter0409-2634a2ab3c41-c4e3-4d1c-9466-66e4ba8567ed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13

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 2 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packagingfab97112-e276-40e0-bc82-0a29d7fa75fa2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.3832ede8-d3fc-455d-ecab-3b77be5869f52026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078591
ndc (package): 0409-2634-01
ndc (package): 0409-2634-10
ndc (package): 0409-2634-25
ndc (package): 0409-2634-50
ndc (package): 0409-2634-05
ndc (product): 0409-2634
ndc11 (package): 00409263410
rxcui: 1724341
rxcui: 1724338
rxcui: 1724340
spl id: 50886ad5-eeca-4fe7-beb0-01305f92c65d
spl set id: 3832ede8-d3fc-455d-ecab-3b77be5869f5
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b325028e-0722-4c8c-9fdb-ab6fb0dc460c2026-03-02Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packaginge4758743-9b2c-4612-8399-ad2db372e2b72026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.cc574063-6ede-4da7-82c4-7450c92b229b2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.f9ca2ef5-46d8-475a-a26e-f7c8becd6db72026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.c729424e-e483-4bf8-b86c-ce56636dcffa2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.e9c9ef18-7dfc-4322-b2fc-29b934c30f8b2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETrigen Laboratories, LLC8bb81796-6990-40e9-bee4-1f292f91ae992025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEPadagis US LLC780a2616-0392-4715-bc50-71799bea19572025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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