FDA.reportPublic FDA data

OXYCODONE HYDROCHLORIDE

Product NDC
0406-0552
11-digit product format
004060552
Labeler code
0406
Product ID
0406-0552_d2534006-67e9-4e2a-a4f8-1e44d5857af5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA076758
Marketing category
ANDA
Marketing start
2004-06-30
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-0552-01OXYCODONE HYDROCHLORIDE100 in 1 BOTTLETABLET10035
0406-0552-23OXYCODONE HYDROCHLORIDE1 in 1 BLISTER PACKTABLET135
0406-0552-62OXYCODONE HYDROCHLORIDE100 in 1 BLISTER PACKTABLET10035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0552-01EA - Each0406-0552d5f1d538-b2c5-42ab-9f85-c1430338abe112012-07-24
0406-0552-23EA - Each0406-05520feb26d5-16b7-49f1-9628-a1c109191a8a12013-03-03
0406-0552-62EA - Each0406-0552c6a85541-9165-43b9-9d68-1f17d1319ee912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]11
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]11
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049683oxyCODONE HCl 10 MG Oral TabletPSN928227bf-89c5-4c64-9823-0e84cc66938835
1049611oxyCODONE HCl 15 MG Oral TabletPSN928227bf-89c5-4c64-9823-0e84cc66938835
1049686oxyCODONE HCl 20 MG Oral TabletPSN928227bf-89c5-4c64-9823-0e84cc66938835
1049618oxyCODONE HCl 30 MG Oral TabletPSN928227bf-89c5-4c64-9823-0e84cc66938835
1049621oxyCODONE HCl 5 MG Oral TabletPSN928227bf-89c5-4c64-9823-0e84cc66938835
1049683oxycodone hydrochloride 10 MG Oral TabletSCD928227bf-89c5-4c64-9823-0e84cc66938835
1049611oxycodone hydrochloride 15 MG Oral TabletSCD928227bf-89c5-4c64-9823-0e84cc66938835
1049686oxycodone hydrochloride 20 MG Oral TabletSCD928227bf-89c5-4c64-9823-0e84cc66938835
1049618oxycodone hydrochloride 30 MG Oral TabletSCD928227bf-89c5-4c64-9823-0e84cc66938835
1049621oxycodone hydrochloride 5 MG Oral TabletSCD928227bf-89c5-4c64-9823-0e84cc66938835
1049621oxyCODONE HCl 5 MG Oral TabletPSN92614a3a-331d-16ad-e053-2a95a90a47cc15
1049621oxycodone hydrochloride 5 MG Oral TabletSCD92614a3a-331d-16ad-e053-2a95a90a47cc15
1049621oxyCODONE HCl 5 MG Oral TabletPSN25c2a91c-dfc2-4596-8a24-63acf04a25681
1049621oxyCODONE HCl 5 MG Oral TabletPSN444d5f08-e491-4ff7-bf35-c26ae972f3ff1
1049621oxycodone hydrochloride 5 MG Oral TabletSCD25c2a91c-dfc2-4596-8a24-63acf04a25681
1049621oxycodone hydrochloride 5 MG Oral TabletSCD444d5f08-e491-4ff7-bf35-c26ae972f3ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-0552-0100406055201100 TABLET in 1 BOTTLE (0406-0552-01) 100 tablet2004-06-300000-00-00NoNoCurrent
0406-0552-23004060552231 TABLET in 1 BLISTER PACK (0406-0552-23) 1 tablet2004-06-300000-00-00NoNoCurrent
0406-0552-6200406055262100 TABLET in 1 BLISTER PACK (0406-0552-62) 100 tablet2004-06-300000-00-00NoNoCurrent