FDA.reportPublic FDA data

Oxymorphone hydrochloride

Product NDC
0115-1234
11-digit product format
001151234
Labeler code
0115
Product ID
0115-1234_a8dc6624-df1e-4e5a-b445-9541658e3430
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxymorphone hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA079087
Marketing category
ANDA
Marketing start
2013-01-02
Substance
OXYMORPHONE HYDROCHLORIDE
Active strength
40 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
Oxymorphone hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMORPHONE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5Y2EI94NBC
Rxcui977874, 977894, 977902, 977909, 977915, 977923, 977929

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
52f0f025-f368-4487-8f9b-49af2656aeebProduct name320201015
3792daf4-c308-47ef-a996-98dc7faa1671Product name220150511
0476a93f-c9eb-691e-8ebf-e5b816d8f47bProduct name120140508
a4b9889e-23ea-ee9f-05f6-4b861fda077bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1234-012024-02-13C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-032024-02-13C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-082024-02-13C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-132024-02-13C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-012024-01-30C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-032024-01-30C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-082024-01-30C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-132024-01-30C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-012020-12-29C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-032020-12-29C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-082020-12-29C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-132020-12-29C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-012020-01-31C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-032020-01-31C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-082020-01-31C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959
0115-1234-132020-01-31C16284748780-19d75b9d0-636a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1234-01Oxymorphone hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10040
0115-1234-03Oxymorphone hydrochloride1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100040
0115-1234-08Oxymorphone hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3040
0115-1234-13Oxymorphone hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6040

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1234OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]40Current NDC, Legacy NDC, 4 package rows20240215_557e9610-62d7-42bf-90c1-44215bd8c1f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977874oxyMORphone HCl 10 MG 12HR Extended Release Oral TabletPSN557e9610-62d7-42bf-90c1-44215bd8c1f840
977894oxyMORphone HCl 15 MG 12HR Extended Release Oral TabletPSN557e9610-62d7-42bf-90c1-44215bd8c1f840
977902oxyMORphone HCl 20 MG 12HR Extended Release Oral TabletPSN557e9610-62d7-42bf-90c1-44215bd8c1f840
977909oxyMORphone HCl 30 MG 12HR Extended Release Oral TabletPSN557e9610-62d7-42bf-90c1-44215bd8c1f840
977915oxyMORphone HCl 40 MG 12HR Extended Release Oral TabletPSN557e9610-62d7-42bf-90c1-44215bd8c1f840
977923oxyMORphone HCl 5 MG 12HR Extended Release Oral TabletPSN557e9610-62d7-42bf-90c1-44215bd8c1f840
977929oxyMORphone HCl 7.5 MG 12HR Extended Release Oral TabletPSN557e9610-62d7-42bf-90c1-44215bd8c1f840
97787412 HR oxymorphone hydrochloride 10 MG Extended Release Oral TabletSCD557e9610-62d7-42bf-90c1-44215bd8c1f840
97789412 HR oxymorphone hydrochloride 15 MG Extended Release Oral TabletSCD557e9610-62d7-42bf-90c1-44215bd8c1f840
97790212 HR oxymorphone hydrochloride 20 MG Extended Release Oral TabletSCD557e9610-62d7-42bf-90c1-44215bd8c1f840
97790912 HR oxymorphone hydrochloride 30 MG Extended Release Oral TabletSCD557e9610-62d7-42bf-90c1-44215bd8c1f840
97791512 HR oxymorphone hydrochloride 40 MG Extended Release Oral TabletSCD557e9610-62d7-42bf-90c1-44215bd8c1f840
97792312 HR oxymorphone hydrochloride 5 MG Extended Release Oral TabletSCD557e9610-62d7-42bf-90c1-44215bd8c1f840
97792912 HR oxymorphone hydrochloride 7.5 MG Extended Release Oral TabletSCD557e9610-62d7-42bf-90c1-44215bd8c1f840
977874oxymorphone hydrochloride 10 MG 12 HR Extended Release Oral TabletSY557e9610-62d7-42bf-90c1-44215bd8c1f840
977894oxymorphone hydrochloride 15 MG 12 HR Extended Release Oral TabletSY557e9610-62d7-42bf-90c1-44215bd8c1f840
977902oxymorphone hydrochloride 20 MG 12 HR Extended Release Oral TabletSY557e9610-62d7-42bf-90c1-44215bd8c1f840
977909oxymorphone hydrochloride 30 MG 12 HR Extended Release Oral TabletSY557e9610-62d7-42bf-90c1-44215bd8c1f840
977915oxymorphone hydrochloride 40 MG 12 HR Extended Release Oral TabletSY557e9610-62d7-42bf-90c1-44215bd8c1f840
977923oxymorphone hydrochloride 5 MG 12 HR Extended Release Oral TabletSY557e9610-62d7-42bf-90c1-44215bd8c1f840
977929oxymorphone hydrochloride 7.5 MG 12 HR Extended Release Oral TabletSY557e9610-62d7-42bf-90c1-44215bd8c1f840

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1234-0100115123401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1234-01) 2013-01-020000-00-00NoNoCurrent
0115-1234-03001151234031000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1234-03) 2013-01-020000-00-00NoNoCurrent
0115-1234-080011512340830 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1234-08) 2013-01-020000-00-00NoNoCurrent
0115-1234-130011512341360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1234-13) 2013-01-020000-00-00NoNoCurrent