Oxycodone Hydrochloride

Product NDC
68462-204
11-digit product format
684620204
Labeler code
68462
Product ID
68462-204_5a288bc7-4ba4-45a9-ae81-9c3f675524be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals, Inc
Application
NDA200534
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-12-15
Marketing end
0000-00-00
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
2020-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-204-01Oxycodone Hydrochloride100 in 1 BOTTLECAPSULE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-204-01EA - Each68462-2043147c7dc-c342-4538-bd49-e101ae66279712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxycodone HydrochlorideACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2
OxycodoneACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2
LactoseINACTIVE INGREDIENTJ2B2A4N98GOXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JOXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK GENERICS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-204OXYCODONE HYDROCHLORIDE CAPSULE [GLENMARK PHARMACEUTICALS, INC]5Legacy NDC, 1 package rows20181218_566ef74d-5c0b-49bf-9619-e757d16431ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049696oxyCODONE HCl 5 MG Oral CapsulePSN566ef74d-5c0b-49bf-9619-e757d16431ef5
1049696oxycodone hydrochloride 5 MG Oral CapsuleSCD566ef74d-5c0b-49bf-9619-e757d16431ef5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-204-0168462020401100 CAPSULE in 1 BOTTLE (68462-204-01) 100 capsule2010-12-150000-00-00NoNoCurrent