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 11 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 6DC9Q167V3
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: 506T60A25R
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
unii: 6DC9Q167V3
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEAurolife Pharma, LLCf778dfab-e109-428e-b1b7-4dfb1b8293e42023-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897710
rxcui: 897702
unii: L960UP2KRW
Equate Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.91f85a72-5270-e4db-e053-2995a90aeb212023-12-23WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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