FDA.reportPublic FDA data

NDC 0703-0113-01 - 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
0703-0113
Requested NDC
0703-0113-01
Package NDCs from labels
0703-0113-01, 0703-0113-03
Manufacturer
Teva Parenteral Medicines, Inc. | Hospira, Inc.
Effective date
2026-05-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydromorphone Hydrochloride - Teva Parenteral Medicines, Inc. | Hospira, Inc.Teva Parenteral Medicines, Inc. | Hospira, Inc.2026-05-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0703-0113-01Hydromorphone Hydrochloride5 mL in 1 VIALINJECTION, SOLUTION515
0703-0113-03Hydromorphone Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0703-0113HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]14Current NDC, Legacy NDC, 2 package rows20250508_f0b78db9-a38c-41bb-8233-5e93f7f18c5c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-0113-01ML - Milliliter0703-0113e76fb581-df13-492e-91d5-9ef504cbf97812013-02-13
0703-0113-03ML - Milliliter0703-011346ec7f2d-2120-4363-95d9-56b4adc12ea012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]3
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]3

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 5 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.90bda45c-9dbe-4ed5-91d0-df8446ad70262024-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackbec32a94-4b79-4bd4-b000-45e9030d31062024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEAurolife Pharma, LLCf778dfab-e109-428e-b1b7-4dfb1b8293e42023-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEPadagis US LLC1bfbba46-1979-4797-a29e-d677181316862023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 1Q73Q2JULR
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAscent Pharmaceuticals Ince8fd7b0e-22b9-4f8a-8eb2-41d5031779af2017-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW

Reported adverse events (FAERS/openFDA)#

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