FDA.reportPublic FDA data

NDC 71335-9701-04 - 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
71335-9701
Requested NDC
71335-9701-04
Package NDCs from labels
71335-9701-1, 71335-9701-2, 71335-9701-3, 71335-9701-4, 71335-9701-5, 71335-9701-6, 71335-9701-7, 71335-9701-8, 71335-9701-9, 71335-9701-0, 71335-9701-04
Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydromorphone Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2026-04-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9701-0Hydromorphone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET90104
71335-9701-1Hydromorphone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET30104
71335-9701-2Hydromorphone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET180104
71335-9701-3Hydromorphone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET120104
71335-9701-4Hydromorphone Hydrochloride20 in 1 BOTTLE, PLASTICTABLET20104
71335-9701-5Hydromorphone Hydrochloride25 in 1 BOTTLE, PLASTICTABLET25104
71335-9701-6Hydromorphone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100104
71335-9701-7Hydromorphone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET60104
71335-9701-8Hydromorphone Hydrochloride56 in 1 BOTTLE, PLASTICTABLET56104
71335-9701-9Hydromorphone Hydrochloride140 in 1 BOTTLE, PLASTICTABLET140104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9701HYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, 10 package rows20250303_c48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9701-0EA - Each71335-970120b95f91-80dc-4662-88e7-a6f283b88da712025-05-14
71335-9701-1EA - Each71335-970164219e21-7222-44d7-b597-ea0ab5aa25aa12025-05-14
71335-9701-7EA - Each71335-9701ad4af359-9c1a-4093-8437-635941cd2fdf12025-05-14

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 2 · 31 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
rxcui: 897696
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.67e79859-4efc-4ea7-8211-cadf746bc8642026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
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
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLCe034eb96-03e0-46e1-8b92-5e1f94555e7b2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESpecGx LLC4c5c1cc8-c42b-46e3-ad68-8e22f57101f22026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897710
rxcui: 897702
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack2427814c-f32b-8ac5-99b8-5e886fd2d0012026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019892
rxcui: 897696
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy53ddcacc-99e4-8b21-e063-6394a90a3e792026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019892
rxcui: 897702
unii: L960UP2KRW
DilaudidHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLCd6b40e39-a57e-402c-b4f6-7041e832f8372026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019892
rxcui: 897696
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
application number: NDA019892
ndc (product): 42858-302
rxcui: 897696
rxcui: 897657
rxcui: 897710
rxcui: 897702
spl id: b786b01b-46f9-4a00-a667-699e813a741b
spl set id: 37565441-0d95-4743-a695-d7b3326f58a1
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packagingfab97112-e276-40e0-bc82-0a29d7fa75fa2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897657
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.3832ede8-d3fc-455d-ecab-3b77be5869f52026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019892
ndc (package): 71335-9701-9
ndc (package): 71335-9701-4
ndc (package): 71335-9701-6
ndc (package): 71335-9701-2
ndc (package): 71335-9701-3
ndc (package): 71335-9701-1
ndc (package): 71335-9701-7
ndc (package): 71335-9701-0
ndc (package): 71335-9701-5
ndc (package): 71335-9701-8
ndc (product): 71335-9701
ndc11 (package): 71335970104
rxcui: 897702
spl id: b9b96266-fe94-4282-915f-277433e1ca26
spl set id: c48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b325028e-0722-4c8c-9fdb-ab6fb0dc460c2026-03-02Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packaginge4758743-9b2c-4612-8399-ad2db372e2b72026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897696
rxcui: 897702
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.cc574063-6ede-4da7-82c4-7450c92b229b2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897657
rxcui: 897710
rxcui: 897702
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.f9ca2ef5-46d8-475a-a26e-f7c8becd6db72026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.c729424e-e483-4bf8-b86c-ce56636dcffa2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.e9c9ef18-7dfc-4322-b2fc-29b934c30f8b2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW

Reported adverse events (FAERS/openFDA)#

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