FDA.reportPublic FDA data

Oxycodone Hydchloride

Product NDC
49999-899
11-digit product format
499990899
Labeler code
49999
Product ID
49999-899_13014be8-5073-42af-b13d-af29c8b906ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydchloride
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA091393
Marketing category
ANDA
Marketing start
2011-12-20
Marketing end
2027-06-30
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone Hydchloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049621

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49999-899-00Oxycodone Hydchloride100 in 1 BOTTLETABLET1003413
49999-899-15Oxycodone Hydchloride15 in 1 BOTTLETABLET153413
49999-899-21Oxycodone Hydchloride21 in 1 BOTTLETABLET213413
49999-899-30Oxycodone Hydchloride30 in 1 BOTTLETABLET303413
49999-899-40Oxycodone Hydchloride40 in 1 BOTTLETABLET403413
49999-899-60Oxycodone Hydchloride60 in 1 BOTTLETABLET603413
49999-899-90Oxycodone Hydchloride90 in 1 BOTTLETABLET903413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-899-15EA - Each49999-899ee1de391-eed1-4fef-b768-577ac33e722e12019-07-02
49999-899-21EA - Each49999-899e395d211-b6dc-43cd-b91f-03d09c89a3c412019-07-02
49999-899-30EA - Each49999-899124c2c8f-a71c-4a48-bd12-a12436c4791112012-07-24
49999-899-40EA - Each49999-899c8f73651-b3a0-44a5-be7d-6a6e7d804ef412012-07-24
49999-899-60EA - Each49999-899807b0724-4daa-49f6-8a17-9cf7c73cdd0212012-07-24
49999-899-90EA - Each49999-899a30dc3cf-6e4d-4f77-a0e1-ebce5823b17312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3405
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-899OXYCODONE HYDCHLORIDE TABLET [QUALITY CARE PRODUCTS LLC]3413Current NDC, Legacy NDC, 7 package rows20241222_b9847cc7-67a2-408d-93cf-f9cf420346dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049621oxyCODONE HCl 5 MG Oral TabletPSNb9847cc7-67a2-408d-93cf-f9cf420346dd3413
1049621oxycodone hydrochloride 5 MG Oral TabletSCDb9847cc7-67a2-408d-93cf-f9cf420346dd3413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-899-0049999089900100 in 1 BOTTLEHistorical
49999-899-154999908991515 TABLET in 1 BOTTLE (49999-899-15) 15 tablet2019-06-142027-06-30NoNoCurrent
49999-899-214999908992121 TABLET in 1 BOTTLE (49999-899-21) 21 tablet2019-06-142026-06-30NoNoCurrent
49999-899-304999908993030 TABLET in 1 BOTTLE (49999-899-30) 30 tablet2011-12-202027-06-30NoNoCurrent
49999-899-404999908994040 TABLET in 1 BOTTLE (49999-899-40) 40 tablet2011-12-200000-00-00NoNoCurrent
49999-899-604999908996060 TABLET in 1 BOTTLE (49999-899-60) 60 tablet2011-12-202027-06-30NoNoCurrent
49999-899-904999908999090 TABLET in 1 BOTTLE (49999-899-90) 90 tablet2011-12-202026-06-30NoNoCurrent