FDA.reportPublic FDA data

Oxymorphone hydrochloride

Product NDC
64896-701
11-digit product format
648960701
Labeler code
64896
Product ID
64896-701_4f08b804-ef2d-4c9b-8553-c2bc7fa1fd71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxymorphone hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxymorphone hydrochloride
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64896-701-01Oxymorphone hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10015
64896-701-03Oxymorphone hydrochloride1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100015
64896-701-08Oxymorphone hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3015
64896-701-13Oxymorphone hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64896-701OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 4 package rows20241025_3f4e703a-e398-42fd-8759-e398c79955f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977874oxyMORphone HCl 10 MG 12HR Extended Release Oral TabletPSN3f4e703a-e398-42fd-8759-e398c79955f115
977894oxyMORphone HCl 15 MG 12HR Extended Release Oral TabletPSN3f4e703a-e398-42fd-8759-e398c79955f115
977902oxyMORphone HCl 20 MG 12HR Extended Release Oral TabletPSN3f4e703a-e398-42fd-8759-e398c79955f115
977909oxyMORphone HCl 30 MG 12HR Extended Release Oral TabletPSN3f4e703a-e398-42fd-8759-e398c79955f115
977915oxyMORphone HCl 40 MG 12HR Extended Release Oral TabletPSN3f4e703a-e398-42fd-8759-e398c79955f115
977923oxyMORphone HCl 5 MG 12HR Extended Release Oral TabletPSN3f4e703a-e398-42fd-8759-e398c79955f115
977929oxyMORphone HCl 7.5 MG 12HR Extended Release Oral TabletPSN3f4e703a-e398-42fd-8759-e398c79955f115
97787412 HR oxymorphone hydrochloride 10 MG Extended Release Oral TabletSCD3f4e703a-e398-42fd-8759-e398c79955f115
97789412 HR oxymorphone hydrochloride 15 MG Extended Release Oral TabletSCD3f4e703a-e398-42fd-8759-e398c79955f115
97790212 HR oxymorphone hydrochloride 20 MG Extended Release Oral TabletSCD3f4e703a-e398-42fd-8759-e398c79955f115
97790912 HR oxymorphone hydrochloride 30 MG Extended Release Oral TabletSCD3f4e703a-e398-42fd-8759-e398c79955f115
97791512 HR oxymorphone hydrochloride 40 MG Extended Release Oral TabletSCD3f4e703a-e398-42fd-8759-e398c79955f115
97792312 HR oxymorphone hydrochloride 5 MG Extended Release Oral TabletSCD3f4e703a-e398-42fd-8759-e398c79955f115
97792912 HR oxymorphone hydrochloride 7.5 MG Extended Release Oral TabletSCD3f4e703a-e398-42fd-8759-e398c79955f115
977874oxymorphone hydrochloride 10 MG 12 HR Extended Release Oral TabletSY3f4e703a-e398-42fd-8759-e398c79955f115
977894oxymorphone hydrochloride 15 MG 12 HR Extended Release Oral TabletSY3f4e703a-e398-42fd-8759-e398c79955f115
977902oxymorphone hydrochloride 20 MG 12 HR Extended Release Oral TabletSY3f4e703a-e398-42fd-8759-e398c79955f115
977909oxymorphone hydrochloride 30 MG 12 HR Extended Release Oral TabletSY3f4e703a-e398-42fd-8759-e398c79955f115
977915oxymorphone hydrochloride 40 MG 12 HR Extended Release Oral TabletSY3f4e703a-e398-42fd-8759-e398c79955f115
977923oxymorphone hydrochloride 5 MG 12 HR Extended Release Oral TabletSY3f4e703a-e398-42fd-8759-e398c79955f115
977929oxymorphone hydrochloride 7.5 MG 12 HR Extended Release Oral TabletSY3f4e703a-e398-42fd-8759-e398c79955f115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64896-701-0164896070101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-01) 2013-01-020000-00-00NoNoCurrent
64896-701-03648960701031000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-03) 2013-01-020000-00-00NoNoCurrent
64896-701-086489607010830 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-08) 2013-01-020000-00-00NoNoCurrent
64896-701-136489607011360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-701-13) 2013-01-020000-00-00NoNoCurrent