FDA.reportPublic FDA data

OXYCODONE HYDROCHLORIDE

Product NDC
10702-056
11-digit product format
107020056
Labeler code
10702
Product ID
10702-056_31f901b4-04ad-38aa-e063-6294a90ac708
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH,INC
Application
ANDA091393
Marketing category
ANDA
Marketing start
2013-10-18
Substance
OXYCODONE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
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 HYDROCHLORIDE10 mg/1

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
10702-056-01OXYCODONE HYDROCHLORIDE100 in 1 BOTTLETABLET10015
10702-056-50OXYCODONE HYDROCHLORIDE500 in 1 BOTTLETABLET50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-056-01EA - Each10702-056f8239baf-bc0d-4458-8ac7-cbf39c58266312012-07-24
10702-056-50EA - Each10702-056e6debc60-8cac-4b7f-b8f0-06c9181b79d412015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KOXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-056OXYCODONE HYDROCHLORIDE TABLET [KVK-TECH,INC]15Current NDC, Legacy NDC, 2 package rows20250409_e73897d6-b920-4300-a564-5dbc9c8e9fe9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049683oxyCODONE HCl 10 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049611oxyCODONE HCl 15 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049686oxyCODONE HCl 20 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049618oxyCODONE HCl 30 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049621oxyCODONE HCl 5 MG Oral TabletPSNe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049683oxycodone hydrochloride 10 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049611oxycodone hydrochloride 15 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049686oxycodone hydrochloride 20 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049618oxycodone hydrochloride 30 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049621oxycodone hydrochloride 5 MG Oral TabletSCDe73897d6-b920-4300-a564-5dbc9c8e9fe915
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNa8206207-ad09-83df-e053-2995a90a78b710
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSNa8206207-ad09-83df-e053-2995a90a78b710
1049683oxyCODONE HCl 10 MG Oral TabletPSNa8206207-ad09-83df-e053-2995a90a78b710
1049683oxyCODONE HCl 10 MG Oral TabletPSNaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049611oxyCODONE HCl 15 MG Oral TabletPSNaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049618oxyCODONE HCl 30 MG Oral TabletPSNaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049621oxyCODONE HCl 5 MG Oral TabletPSNa8206207-ad09-83df-e053-2995a90a78b710
1049621oxyCODONE HCl 5 MG Oral TabletPSNaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDa8206207-ad09-83df-e053-2995a90a78b710
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCDa8206207-ad09-83df-e053-2995a90a78b710
1049683oxycodone hydrochloride 10 MG Oral TabletSCDaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049683oxycodone hydrochloride 10 MG Oral TabletSCDa8206207-ad09-83df-e053-2995a90a78b710
1049611oxycodone hydrochloride 15 MG Oral TabletSCDaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049618oxycodone hydrochloride 30 MG Oral TabletSCDaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049621oxycodone hydrochloride 5 MG Oral TabletSCDaa7ac2bf-d9ed-445d-b394-4d3fe39780ca10
1049621oxycodone hydrochloride 5 MG Oral TabletSCDa8206207-ad09-83df-e053-2995a90a78b710
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYa8206207-ad09-83df-e053-2995a90a78b710
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSYa8206207-ad09-83df-e053-2995a90a78b710
1049683oxyCODONE HCl 10 MG Oral TabletPSN28156b13-0ba9-4dc4-be24-9c3070a7e1cc7
1049683oxycodone hydrochloride 10 MG Oral TabletSCD28156b13-0ba9-4dc4-be24-9c3070a7e1cc7
1049683oxyCODONE HCl 10 MG Oral TabletPSN3cd01fb7-b59c-fc5d-e063-6394a90a21d21
1049683oxycodone hydrochloride 10 MG Oral TabletSCD3cd01fb7-b59c-fc5d-e063-6394a90a21d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-056-0110702005601100 TABLET in 1 BOTTLE (10702-056-01) 100 tablet2013-10-180000-00-00NoNoCurrent
10702-056-5010702005650500 TABLET in 1 BOTTLE (10702-056-50) 500 tablet2013-10-180000-00-00NoNoCurrent