FDA.reportPublic FDA data

Butrans

Product NDC
59011-758
11-digit product format
590110758
Labeler code
59011
Product ID
59011-758_cf5d162f-a313-4f27-a292-3ecf640fbea7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Knoa Pharma LLC
Application
NDA021306
Marketing category
NDA
Marketing start
2011-02-14
Substance
BUPRENORPHINE
Active strength
15 ug/h
Pharmacologic classes
Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE15 ug/h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40D3SCR4GZ
Rxcui904870, 904874, 904876, 904878, 904880, 904882, 1432969, 1432971, 1542997, 1542999

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59011-758-04Butrans1 in 1 POUCHPATCH, EXTENDED RELEASE132
59011-758-04Butrans4 in 1 CARTONPATCH, EXTENDED RELEASE432

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59011-758-04EA - Each59011-758dc32607c-ac9c-442e-adac-e70c46d3dbce12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
buprenorphineACTIVE INGREDIENT40D3SCR4GZBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]15
buprenorphineACTIVE MOIETY40D3SCR4GZBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]15
ETHYL LEVULINATEINACTIVE INGREDIENT7BU24CSS2GBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]15
OLEYL OLEATEINACTIVE INGREDIENT3X3L452Y85BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]15
POVIDONEINACTIVE INGREDIENTFZ989GH94EBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59011-758BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]29Current NDC, Legacy NDC, 2 package rows20240619_794aa355-66de-41b8-aedf-f2c40f6bc664.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904870buprenorphine 10 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
1432969buprenorphine 15 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
904876buprenorphine 20 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
904880buprenorphine 5 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
1542997buprenorphine 7.5 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
904874Butrans 10 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
1432971Butrans 15 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
904878Butrans 20 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
904882Butrans 5 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
1542999Butrans 7.5 MCG/HR 7 Day Transdermal SystemPSN794aa355-66de-41b8-aedf-f2c40f6bc66432
904882168 HR buprenorphine 0.005 MG/HR Transdermal System [BuTrans]SBD794aa355-66de-41b8-aedf-f2c40f6bc66432
1542999168 HR buprenorphine 0.0075 MG/HR Transdermal System [BuTrans]SBD794aa355-66de-41b8-aedf-f2c40f6bc66432
904874168 HR buprenorphine 0.01 MG/HR Transdermal System [BuTrans]SBD794aa355-66de-41b8-aedf-f2c40f6bc66432
1432971168 HR buprenorphine 0.015 MG/HR Transdermal System [BuTrans]SBD794aa355-66de-41b8-aedf-f2c40f6bc66432
904878168 HR buprenorphine 0.02 MG/HR Transdermal System [BuTrans]SBD794aa355-66de-41b8-aedf-f2c40f6bc66432
904880168 HR buprenorphine 0.005 MG/HR Transdermal SystemSCD794aa355-66de-41b8-aedf-f2c40f6bc66432
1542997168 HR buprenorphine 0.0075 MG/HR Transdermal SystemSCD794aa355-66de-41b8-aedf-f2c40f6bc66432
904870168 HR buprenorphine 0.01 MG/HR Transdermal SystemSCD794aa355-66de-41b8-aedf-f2c40f6bc66432
1432969168 HR buprenorphine 0.015 MG/HR Transdermal SystemSCD794aa355-66de-41b8-aedf-f2c40f6bc66432
904876168 HR buprenorphine 0.02 MG/HR Transdermal SystemSCD794aa355-66de-41b8-aedf-f2c40f6bc66432
904882168 HR BuTrans 0.005 MG/HR Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1542999168 HR BuTrans 0.0075 MG/HR Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904874168 HR BuTrans 0.01 MG/HR Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1432971168 HR BuTrans 0.015 MG/HR Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904878168 HR BuTrans 0.02 MG/HR Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904870buprenorphine 10 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904870buprenorphine 10 MCG/HR Weekly Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1432969buprenorphine 15 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1432969buprenorphine 15 MCG/HR Weekly Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904876buprenorphine 20 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904876buprenorphine 20 MCG/HR Weekly Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904880buprenorphine 5 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904880buprenorphine 5 MCG/HR Weekly Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1542997buprenorphine 7.5 MCG/HR 7 Day Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1542997buprenorphine 7.5 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904874Butrans 10 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904874BuTrans 10 MCG/HR Weekly Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1432971Butrans 15 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1432971BuTrans 15 MCG/HR Weekly Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904878Butrans 20 MCG/HR 7 Day Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904878Butrans 20 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904882Butrans 5 MCG/HR 7 Day Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
904882Butrans 5 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1542999BuTrans 7.5 MCG/HR 7 Day Transdermal PatchSY794aa355-66de-41b8-aedf-f2c40f6bc66432
1542999Butrans 7.5 MCG/HR 7 Day Transdermal SystemSY794aa355-66de-41b8-aedf-f2c40f6bc66432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59011-758-04590110758044 POUCH in 1 CARTON (59011-758-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH4 pouch2011-02-140000-00-00NoNoCurrent