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 1 of 15 · 297 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDERedpharm Drug59d88866-e1ba-9d97-e063-6394a90a7b272026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.67e79859-4efc-4ea7-8211-cadf746bc8642026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.31d5a37a-0e90-4e88-be14-75c877be9de22026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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