FDA.reportPublic FDA data

XTAMPZA

Product NDC
24510-120
11-digit product format
245100120
Labeler code
24510
Product ID
24510-120_fda0989d-9319-4e35-af83-fca1ec66878e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Collegium Pharmaceutical, Inc.
Application
NDA208090
Marketing category
NDA
Marketing start
2016-05-10
Substance
OXYCODONE
Active strength
18 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
XTAMPZA
Brand name suffix
ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE18 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCD35PMG570
Rxcui1790527, 1790533, 1791558, 1791560, 1791567, 1791569, 1791574, 1791576, 1791580, 1791582

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
24510-120-10XTAMPZA ER100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE10011
24510-120-20XTAMPZA ER20 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE2011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24510-120-10EA - Each24510-120e75f0082-3eef-4bb8-8404-2f931f07c47f12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24510-120XTAMPZA ER (OXYCODONE) CAPSULE, EXTENDED RELEASE [COLLEGIUM PHARMACEUTICAL, INC.]10Current NDC, Legacy NDC, 2 package rows20231223_b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791558oxyCODONE 13.5 MG 12HR Extended Release Oral Capsule, Abuse-DeterrentPSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791567oxyCODONE 18 MG 12HR Extended Release Oral Capsule, Abuse-DeterrentPSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791574oxyCODONE 27 MG 12HR Extended Release Oral Capsule, Abuse-DeterrentPSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791580oxyCODONE 36 MG 12HR Extended Release Oral Capsule, Abuse-DeterrentPSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1790527oxyCODONE 9 MG 12HR Extended Release Oral Capsule, Abuse-DeterrentPSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791560Xtampza ER 13.5 MG 12HR Extended Release Oral CapsulePSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791569Xtampza ER 18 MG 12HR Extended Release Oral CapsulePSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791576Xtampza ER 27 MG 12HR Extended Release Oral CapsulePSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791582Xtampza ER 36 MG 12HR Extended Release Oral CapsulePSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1790533Xtampza ER 9 MG 12HR Extended Release Oral CapsulePSNb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791560Abuse-Deterrent 12 HR oxycodone 13.5 MG Extended Release Oral Capsule [Xtampza]SBDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791569Abuse-Deterrent 12 HR oxycodone 18 MG Extended Release Oral Capsule [Xtampza]SBDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791576Abuse-Deterrent 12 HR oxycodone 27 MG Extended Release Oral Capsule [Xtampza]SBDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791582Abuse-Deterrent 12 HR oxycodone 36 MG Extended Release Oral Capsule [Xtampza]SBDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1790533Abuse-Deterrent 12 HR oxycodone 9 MG Extended Release Oral Capsule [Xtampza]SBDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791558Abuse-Deterrent 12 HR oxycodone 13.5 MG Extended Release Oral CapsuleSCDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791567Abuse-Deterrent 12 HR oxycodone 18 MG Extended Release Oral CapsuleSCDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791574Abuse-Deterrent 12 HR oxycodone 27 MG Extended Release Oral CapsuleSCDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791580Abuse-Deterrent 12 HR oxycodone 36 MG Extended Release Oral CapsuleSCDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1790527Abuse-Deterrent 12 HR oxycodone 9 MG Extended Release Oral CapsuleSCDb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791558oxycodone 13.5 MG (equivalent to 15 MG oxycodone HCl) 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791558oxycodone 13.5 MG 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791567oxycodone 18 MG (equivalent to 20 MG oxycodone HCl) 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791567oxyCODONE 18 MG 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791574oxycodone 27 MG (equivalent to 30 MG oxycodone HCl) 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791574oxycodone 27 MG 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791580oxycodone 36 MG (equivalent to 40 MG oxycodone HCl) 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791580oxycodone 36 MG 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1790527oxycodone 9 MG (equivalent to 10 MG oxycodone HCl) 12 HR Extended Release Oral Capsule 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1790527oxycodone 9 MG 12 HR Extended Release Oral Capsule, Abuse-DeterrentSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791560Xtampza ER 13.5 MG (equivalent to 15 MG oxycodone HCl) 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791560Xtampza ER 13.5 MG 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791569Xtampza ER 18 MG (equivalent to 20 MG oxycodone HCl) 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791569Xtampza ER 18 MG 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791576Xtampza ER 27 MG (equivalent to oxycodone hydrochloride 30 MG) 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791576Xtampza ER 27 MG 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791582Xtampza ER 36 MG (equivalent to 40 MG oxycodone HCl) 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1791582Xtampza ER 36 MG 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1790533Xtampza ER 9 MG (equivalent to 10 MG oxycodone HCl) 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11
1790533Xtampza ER 9 MG 12 HR Extended Release Oral CapsuleSYb0a5ded2-8ee2-49ca-a86c-2b28ae40f60c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24510-120-1024510012010100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-120-10) 2016-05-100000-00-00NoNoCurrent
24510-120-202451001202020 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-120-20) 2016-05-100000-00-00NoNoCurrent