FDA.reportPublic FDA data

HYDROMORPHONE HYDROCHLORIDE

Product NDC
71335-0723
11-digit product format
713350723
Labeler code
71335
Product ID
71335-0723_dd7057dd-4448-4f11-8c2d-6a1bfe0e1f50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROMORPHONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205814
Marketing category
ANDA
Marketing start
2016-05-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROMORPHONE HYDROCHLORIDE
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0723-02024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-12024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-22024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-32024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-42024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-52024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-62024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-72024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-82024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-92024-08-20C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-02024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-12024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-22024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-32024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-42024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-52024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-62024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-72024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-82024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984
71335-0723-92024-01-30C16284748780-11030e365-3774-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS. HYDROMORPHONE HYDROCHLORIDE tablets, for oral use, C-II Initial U.S. Approval: January 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0723-0HYDROMORPHONE HYDROCHLORIDE90 in 1 BOTTLETABLET906
71335-0723-1HYDROMORPHONE HYDROCHLORIDE30 in 1 BOTTLETABLET306
71335-0723-2HYDROMORPHONE HYDROCHLORIDE180 in 1 BOTTLETABLET1806
71335-0723-3HYDROMORPHONE HYDROCHLORIDE120 in 1 BOTTLETABLET1206
71335-0723-4HYDROMORPHONE HYDROCHLORIDE20 in 1 BOTTLETABLET206
71335-0723-5HYDROMORPHONE HYDROCHLORIDE25 in 1 BOTTLETABLET256
71335-0723-6HYDROMORPHONE HYDROCHLORIDE100 in 1 BOTTLETABLET1006
71335-0723-7HYDROMORPHONE HYDROCHLORIDE60 in 1 BOTTLETABLET606
71335-0723-8HYDROMORPHONE HYDROCHLORIDE56 in 1 BOTTLETABLET566
71335-0723-9HYDROMORPHONE HYDROCHLORIDE140 in 1 BOTTLETABLET1406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0723-1EA - Each71335-072340c6c375-7470-4582-83bf-98d4f6bfb9fb12018-06-11
71335-0723-7EA - Each71335-072367fb11b5-7daa-48e6-8bb4-2ffb2b1ef97a12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0723HYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240822_29765ff0-3b1d-47da-953e-28bf0e6a56ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897702HYDROmorphone HCl 4 MG Oral TabletPSN29765ff0-3b1d-47da-953e-28bf0e6a56ef6
897702hydromorphone hydrochloride 4 MG Oral TabletSCD29765ff0-3b1d-47da-953e-28bf0e6a56ef6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0723-07133507230090 TABLET in 1 BOTTLE (71335-0723-0) 90 tablet2018-04-160000-00-00NoNoCurrent
71335-0723-17133507230130 TABLET in 1 BOTTLE (71335-0723-1) 30 tablet2018-03-080000-00-00NoNoCurrent
71335-0723-271335072302180 TABLET in 1 BOTTLE (71335-0723-2) 180 tablet2024-08-090000-00-00NoNoCurrent
71335-0723-371335072303120 TABLET in 1 BOTTLE (71335-0723-3) 120 tablet2024-08-090000-00-00NoNoCurrent
71335-0723-47133507230420 TABLET in 1 BOTTLE (71335-0723-4) 20 tablet2024-08-090000-00-00NoNoCurrent
71335-0723-57133507230525 TABLET in 1 BOTTLE (71335-0723-5) 25 tablet2024-08-090000-00-00NoNoCurrent
71335-0723-671335072306100 TABLET in 1 BOTTLE (71335-0723-6) 100 tablet2024-08-090000-00-00NoNoCurrent
71335-0723-77133507230760 TABLET in 1 BOTTLE (71335-0723-7) 60 tablet2018-04-160000-00-00NoNoCurrent
71335-0723-87133507230856 TABLET in 1 BOTTLE (71335-0723-8) 56 tablet2024-08-090000-00-00NoNoCurrent
71335-0723-971335072309140 TABLET in 1 BOTTLE (71335-0723-9) 140 tablet2024-08-090000-00-00NoNoCurrent