Oxycodone Hydrochloride

Product NDC
0603-4992
11-digit product format
006034992
Labeler code
0603
Product ID
0603-4992_54873134-c3ba-43c2-98b1-df36c08c74d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA077712
Marketing category
ANDA
Marketing start
2007-01-31
Marketing end
2020-02-29
Substance
OXYCODONE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-4992-21EA - Each0603-49924016ab5d-7119-443e-bdde-827eaf4543db12012-07-24
0603-4992-28EA - Each0603-4992d0b10fc2-74e0-4ae8-8f99-c324b54a0d4112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSN994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049618oxyCODONE HCl 30 MG Oral TabletPSN994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049621oxyCODONE HCl 5 MG Oral TabletPSN994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049611oxycodone hydrochloride 15 MG Oral TabletSCD994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049618oxycodone hydrochloride 30 MG Oral TabletSCD994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049621oxycodone hydrochloride 5 MG Oral TabletSCD994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049611oxyCODONE HCl 15 MG Oral TabletPSN603741db-1545-4c6f-ab7c-be9f5f42e49d1
1049618oxyCODONE HCl 30 MG Oral TabletPSN603741db-1545-4c6f-ab7c-be9f5f42e49d1
1049611oxycodone hydrochloride 15 MG Oral TabletSCD603741db-1545-4c6f-ab7c-be9f5f42e49d1
1049618oxycodone hydrochloride 30 MG Oral TabletSCD603741db-1545-4c6f-ab7c-be9f5f42e49d1