FDA.reportPublic FDA data

NDC 0409-4264-11 - 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
0409-4264
Requested NDC
0409-4264-11
Package NDCs from labels
0409-4264-11, 0409-4264-01
Manufacturer
Hospira, Inc.
Effective date
2026-02-04
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.2026-02-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4264-01Hydromorphone Hydrochloride10 in 1 CELLO PACKINJECTION, SOLUTION1012
0409-4264-11Hydromorphone Hydrochloride0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4264HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]9Current NDC, Legacy NDC, 2 package rows20240517_f9ca2ef5-46d8-475a-a26e-f7c8becd6db7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4264-01ML - Milliliter0409-426461447661-c393-43af-a159-b92d8df826ca12022-06-06
0409-4264-11ML - Milliliter0409-4264dc35d8d6-76f7-4c64-9edb-6a9ad37fb1fa12022-06-06

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 3 of 46 · 902 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.31d5a37a-0e90-4e88-be14-75c877be9de22026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1433251
rxcui: 897756
rxcui: 897757
unii: L960UP2KRW
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33X04XA5AT
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
DilaudidHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLC9eebd88a-5632-460f-b7b6-26c8a180540d2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1433251
rxcui: 897756
rxcui: 897757
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLCe034eb96-03e0-46e1-8b92-5e1f94555e7b2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897753
rxcui: 1724276
rxcui: 897653
unii: L960UP2KRW
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5e2105-7125-183c-e063-6394a90ae8792026-07-02WarningsExact identifier
unii: 33X04XA5AT
WART SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5b64a3-b19e-8b1a-e063-6294a90a66412026-07-02WarningsExact identifier
unii: 33X04XA5AT
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESpecGx LLC4c5c1cc8-c42b-46e3-ad68-8e22f57101f22026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack2427814c-f32b-8ac5-99b8-5e886fd2d0012026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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