FDA.reportPublic FDA data

RoxyBond

Product NDC
81140-103
11-digit product format
811400103
Labeler code
81140
Product ID
81140-103_484b1240-1832-049e-e063-6394a90aaa6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Protega Pharmaceuticals Inc
Application
NDA209777
Marketing category
NDA
Marketing start
2017-04-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RoxyBond
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1944529, 1944535, 1944538, 1944540, 1944541, 1944543, 2693194, 2693196

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
81140-103-10RoxyBond100 in 1 BOTTLETABLET, COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81140-103-10EA - Each81140-1032dc1b432-c026-4383-adb6-93ac2f98ac8012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81140-103ROXYBOND (OXYCODONE HYDROCHLORIDE) TABLET, COATED [PROTEGA PHARMACEUTICALS INC]9Current NDC, Legacy NDC, 1 package rows20240915_72398542-8e0a-47b2-afeb-9ca5a1f15083.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2693194oxyCODONE hydrochloride 10 MG Oral Tablet, Abuse-DeterrentPSN72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944529oxyCODONE hydrochloride 15 MG Oral Tablet, Abuse-DeterrentPSN72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944538oxyCODONE hydrochloride 30 MG Oral Tablet, Abuse-DeterrentPSN72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944541oxyCODONE hydrochloride 5 MG Oral Tablet, Abuse-DeterrentPSN72398542-8e0a-47b2-afeb-9ca5a1f1508311
2693196RoxyBond 10 MG Oral TabletPSN72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944535RoxyBond 15 MG Oral TabletPSN72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944540RoxyBond 30 MG Oral TabletPSN72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944543RoxyBond 5 MG Oral TabletPSN72398542-8e0a-47b2-afeb-9ca5a1f1508311
2693196Abuse-Deterrent oxycodone hydrochloride 10 MG Oral Tablet [Roxybond]SBD72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944535Abuse-Deterrent oxycodone hydrochloride 15 MG Oral Tablet [Roxybond]SBD72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944540Abuse-Deterrent oxycodone hydrochloride 30 MG Oral Tablet [Roxybond]SBD72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944543Abuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet [Roxybond]SBD72398542-8e0a-47b2-afeb-9ca5a1f1508311
2693194Abuse-Deterrent oxycodone hydrochloride 10 MG Oral TabletSCD72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944529Abuse-Deterrent oxycodone hydrochloride 15 MG Oral TabletSCD72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944538Abuse-Deterrent oxycodone hydrochloride 30 MG Oral TabletSCD72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944541Abuse-Deterrent oxycodone hydrochloride 5 MG Oral TabletSCD72398542-8e0a-47b2-afeb-9ca5a1f1508311
2693194oxycodone hydrochloride 10 MG (equivalent to oxycodone 9 MG) Oral Tablet, Abuse-DeterrentSY72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944529oxycodone hydrochloride 15 MG (equivalent to oxycodone 13.4 MG) Oral Tablet, Abuse-DeterrentSY72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944538oxycodone hydrochloride 30 MG (equivalent to oxycodone 26.9 MG) Oral Tablet, Abuse-DeterrentSY72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944541oxycodone hydrochloride 5 MG (equivalent to oxycodone 4.5 MG) Oral Tablet, Abuse-DeterrentSY72398542-8e0a-47b2-afeb-9ca5a1f1508311
2693196RoxyBond 10 MG Oral TabletSY72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944535RoxyBond 15 MG Oral TabletSY72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944540RoxyBond 30 MG Oral TabletSY72398542-8e0a-47b2-afeb-9ca5a1f1508311
1944543RoxyBond 5 MG Oral TabletSY72398542-8e0a-47b2-afeb-9ca5a1f1508311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81140-103-1081140010310100 TABLET, COATED in 1 BOTTLE (81140-103-10) 2023-12-190000-00-00NoNoCurrent