FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
42858-001
11-digit product format
428580001
Labeler code
42858
Product ID
42858-001_d95a9c89-1435-4594-be8b-e19e23d07c0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
Application
ANDA091490
Marketing category
ANDA
Marketing start
2014-09-08
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 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
Oxycodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049611, 1049618, 1049621, 1049683, 1049686

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42858-001-012022-08-16C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-012022-08-16C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-012022-08-16C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-102022-08-16C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-102022-08-16C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-102022-08-16C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-012022-07-29C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-012022-07-29C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-012022-07-29C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-102022-07-29C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-102022-07-29C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
42858-001-102022-07-29C16284748780-1e4f33bdf-ad73-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42858-001-01Oxycodone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10026
42858-001-10Oxycodone Hydrochloride10 in 1 BLISTER PACKTABLET1026
42858-001-10Oxycodone Hydrochloride10 in 1 CARTONTABLET1026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-001-01EA - Each42858-001aa9c4aed-463b-4b77-8118-42db34a6f85212014-09-03
42858-001-10EA - Each42858-0013372a3d4-7bb6-448d-8040-b8aaec5fac3612014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]12
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-001OXYCODONE HYDROCHLORIDE TABLET [RHODES PHARMACEUTICALS L.P.]22Current NDC, Legacy NDC, 3 package rows20240430_a5162476-1217-41c0-bc7e-0a0f123f069f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049621oxyCODONE HCl 5 MG Oral TabletPSN1bcddbe1-c453-43ec-a822-9e993b885a5f105
1049621oxycodone hydrochloride 5 MG Oral TabletSCD1bcddbe1-c453-43ec-a822-9e993b885a5f105
1049621oxyCODONE HCl 5 MG Oral TabletPSN7503ef9d-0fad-421f-951a-f35ab71f71c7103
1049621oxycodone hydrochloride 5 MG Oral TabletSCD7503ef9d-0fad-421f-951a-f35ab71f71c7103
1049683oxyCODONE HCl 10 MG Oral TabletPSNa5162476-1217-41c0-bc7e-0a0f123f069f26
1049611oxyCODONE HCl 15 MG Oral TabletPSNa5162476-1217-41c0-bc7e-0a0f123f069f26
1049686oxyCODONE HCl 20 MG Oral TabletPSNa5162476-1217-41c0-bc7e-0a0f123f069f26
1049618oxyCODONE HCl 30 MG Oral TabletPSNa5162476-1217-41c0-bc7e-0a0f123f069f26
1049621oxyCODONE HCl 5 MG Oral TabletPSNa5162476-1217-41c0-bc7e-0a0f123f069f26
1049683oxycodone hydrochloride 10 MG Oral TabletSCDa5162476-1217-41c0-bc7e-0a0f123f069f26
1049611oxycodone hydrochloride 15 MG Oral TabletSCDa5162476-1217-41c0-bc7e-0a0f123f069f26
1049686oxycodone hydrochloride 20 MG Oral TabletSCDa5162476-1217-41c0-bc7e-0a0f123f069f26
1049618oxycodone hydrochloride 30 MG Oral TabletSCDa5162476-1217-41c0-bc7e-0a0f123f069f26
1049621oxycodone hydrochloride 5 MG Oral TabletSCDa5162476-1217-41c0-bc7e-0a0f123f069f26
1049621oxyCODONE HCl 5 MG Oral TabletPSNf45f04ea-5bb9-e8b6-e053-2a95a90a4d842
1049621oxyCODONE HCl 5 MG Oral TabletPSNef58f422-682e-6896-e053-2a95a90a1f2d2
1049621oxycodone hydrochloride 5 MG Oral TabletSCDef58f422-682e-6896-e053-2a95a90a1f2d2
1049621oxycodone hydrochloride 5 MG Oral TabletSCDf45f04ea-5bb9-e8b6-e053-2a95a90a4d842
1049683oxyCODONE HCl 10 MG Oral TabletPSNc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049611oxyCODONE HCl 15 MG Oral TabletPSNc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049686oxyCODONE HCl 20 MG Oral TabletPSNc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049618oxyCODONE HCl 30 MG Oral TabletPSNc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049621oxyCODONE HCl 5 MG Oral TabletPSNc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049683oxycodone hydrochloride 10 MG Oral TabletSCDc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049611oxycodone hydrochloride 15 MG Oral TabletSCDc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049686oxycodone hydrochloride 20 MG Oral TabletSCDc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049618oxycodone hydrochloride 30 MG Oral TabletSCDc10cc127-8756-4ddc-9f46-1e003ef271dc1
1049621oxycodone hydrochloride 5 MG Oral TabletSCDc10cc127-8756-4ddc-9f46-1e003ef271dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-001-0142858000101100 TABLET in 1 BOTTLE, PLASTIC (42858-001-01) 100 tablet2014-09-080000-00-00NoNoCurrent
42858-001-104285800011010 BLISTER PACK in 1 CARTON (42858-001-10) / 10 TABLET in 1 BLISTER PACK10 blister pack2014-09-080000-00-00NoNoCurrent