FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
71335-9701
11-digit product format
713359701
Labeler code
71335
Product ID
71335-9701_b9b96266-fe94-4282-915f-277433e1ca26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA019892
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-11-23
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromorphone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897702

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c92985da-a658-b186-e763-2287eda87a86Product name320250221
96c475b3-58c7-b955-d715-0111804a3e50Product name520210512
1dd54659-b775-4fa8-a858-7f0e521fbadcProduct name420200925

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897702HYDROmorphone HCl 4 MG Oral TabletPSNc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca104
897702hydromorphone hydrochloride 4 MG Oral TabletSCDc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9701-07133597010090 TABLET in 1 BOTTLE, PLASTIC (71335-9701-0) 90 tablet2025-02-26NoNoHistorical
71335-9701-17133597010130 TABLET in 1 BOTTLE, PLASTIC (71335-9701-1) 30 tablet2026-01-12NoNoHistorical
71335-9701-271335970102180 TABLET in 1 BOTTLE, PLASTIC (71335-9701-2) 180 tablet2026-04-10NoNoHistorical
71335-9701-371335970103120 TABLET in 1 BOTTLE, PLASTIC (71335-9701-3) 120 tablet2026-04-10NoNoHistorical
71335-9701-47133597010420 TABLET in 1 BOTTLE, PLASTIC (71335-9701-4) 20 tablet2026-04-10NoNoHistorical
71335-9701-57133597010525 TABLET in 1 BOTTLE, PLASTIC (71335-9701-5) 25 tablet2026-04-10NoNoHistorical
71335-9701-671335970106100 TABLET in 1 BOTTLE, PLASTIC (71335-9701-6) 100 tablet2026-04-10NoNoHistorical
71335-9701-77133597010760 TABLET in 1 BOTTLE, PLASTIC (71335-9701-7) 60 tablet2024-07-30NoNoHistorical
71335-9701-87133597010856 TABLET in 1 BOTTLE, PLASTIC (71335-9701-8) 56 tablet2026-04-10NoNoHistorical
71335-9701-971335970109140 TABLET in 1 BOTTLE, PLASTIC (71335-9701-9) 140 tablet2026-04-10NoNoHistorical