FDA.reportPublic FDA data

NDC 17856-0386-2 - 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
17856-0386
Requested NDC
17856-0386-2
Package NDCs from labels
17856-0386-2, 17856-0386-1
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2024-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydromorphone Hydrochloride - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2024-05-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-15These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
2024-01-30These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
2022-09-22These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
2020-01-31These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0386-1Hydromorphone Hydrochloride72 in 1 CASESOLUTION724
17856-0386-2Hydromorphone Hydrochloride5 mL in 1 CUPSOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0386HYDROMORPHONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 2 package rows20240517_2f1449bd-2b80-4383-9336-df9940e87a50.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0386-1ML - Milliliter17856-0386a3ac3443-c4ca-4c6c-88fb-94d670d967c712022-11-07

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 15 · 297 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
DilaudidHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLCd6b40e39-a57e-402c-b4f6-7041e832f8372026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897657
rxcui: 897710
rxcui: 897702
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.f0b78db9-a38c-41bb-8233-5e93f7f18c5c2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLC37565441-0d95-4743-a695-d7b3326f58a12026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897657
rxcui: 897710
rxcui: 897702
unii: L960UP2KRW
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packagingfab97112-e276-40e0-bc82-0a29d7fa75fa2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897657
unii: L960UP2KRW
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 506T60A25R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.3832ede8-d3fc-455d-ecab-3b77be5869f52026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897702
unii: L960UP2KRW
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b325028e-0722-4c8c-9fdb-ab6fb0dc460c2026-03-02Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW

Reported adverse events (FAERS/openFDA)#

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