FDA.reportPublic FDA data

NDC 63323-853-03 - 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
63323-853
Requested NDC
63323-853-03
Package NDCs from labels
63323-853-03, 63323-853-25
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2026-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydromorphone Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-07-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-853-03Hydromorphone Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION16
63323-853-25Hydromorphone Hydrochloride25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-853HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20250418_e034eb96-03e0-46e1-8b92-5e1f94555e7b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-853-03ML - Milliliter63323-853133cf18c-782a-45d3-ac58-d1fc247fa15c12018-07-03
63323-853-25ML - Milliliter63323-853b27a2023-eacc-424c-822b-bacf82a7178c12018-07-03

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 5 · 96 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
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.67e79859-4efc-4ea7-8211-cadf746bc8642026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724276
unii: L960UP2KRW
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.31d5a37a-0e90-4e88-be14-75c877be9de22026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
DilaudidHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLC9eebd88a-5632-460f-b7b6-26c8a180540d2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019034
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLCe034eb96-03e0-46e1-8b92-5e1f94555e7b2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019034
ndc (package): 63323-854-10
ndc (package): 63323-851-10
ndc (package): 63323-854-03
ndc (package): 63323-852-03
ndc (package): 63323-851-50
ndc (package): 63323-851-03
ndc (package): 63323-851-07
ndc (package): 63323-852-25
ndc (package): 63323-853-25
ndc (package): 63323-851-15
ndc (package): 63323-853-03
ndc (product): 63323-854
ndc (product): 63323-853
ndc (product): 63323-851
ndc (product): 63323-852
ndc11 (package): 63323085303
rxcui: 1724341
rxcui: 897753
rxcui: 1724338
rxcui: 1724276
rxcui: 897653
rxcui: 1724340
spl id: 2cfa0a3e-eb57-4dea-ae2c-0b91176f0f67
spl set id: e034eb96-03e0-46e1-8b92-5e1f94555e7b
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESpecGx LLC4c5c1cc8-c42b-46e3-ad68-8e22f57101f22026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack2427814c-f32b-8ac5-99b8-5e886fd2d0012026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: 1Q73Q2JULR
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy53ddcacc-99e4-8b21-e063-6394a90a3e792026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
DilaudidHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLCd6b40e39-a57e-402c-b4f6-7041e832f8372026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.f0b78db9-a38c-41bb-8233-5e93f7f18c5c2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724341
rxcui: 1724338
rxcui: 1724340
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLC37565441-0d95-4743-a695-d7b3326f58a12026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW

Reported adverse events (FAERS/openFDA)#

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