FDA.reportPublic FDA data

Buprenorphine

Product NDC
69238-1204
11-digit product format
692381204
Labeler code
69238
Product ID
69238-1204_5b776a17-f8cd-413d-934b-fcbe0de7f8d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211586
Marketing category
ANDA
Marketing start
2020-04-20
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
Buprenorphine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE15 ug/h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40D3SCR4GZ
Rxcui904870, 904876, 904880, 1432969, 1542997

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
69238-1204-2Buprenorphine1 in 1 POUCHPATCH, EXTENDED RELEASE119
69238-1204-2Buprenorphine4 in 1 CARTONPATCH, EXTENDED RELEASE419

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1204-2EA - Each69238-1204a8e2e65a-2101-4505-addb-a7ad85b0102812020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1204BUPRENORPHINE PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]18Current NDC, Legacy NDC, 2 package rows20240316_c7d079fb-507f-436f-b794-2171b7d97067.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904870buprenorphine 10 MCG/HR 7 Day Transdermal SystemPSNc7d079fb-507f-436f-b794-2171b7d9706719
1432969buprenorphine 15 MCG/HR 7 Day Transdermal SystemPSNc7d079fb-507f-436f-b794-2171b7d9706719
904876buprenorphine 20 MCG/HR 7 Day Transdermal SystemPSNc7d079fb-507f-436f-b794-2171b7d9706719
904880buprenorphine 5 MCG/HR 7 Day Transdermal SystemPSNc7d079fb-507f-436f-b794-2171b7d9706719
1542997buprenorphine 7.5 MCG/HR 7 Day Transdermal SystemPSNc7d079fb-507f-436f-b794-2171b7d9706719
904880168 HR buprenorphine 0.005 MG/HR Transdermal SystemSCDc7d079fb-507f-436f-b794-2171b7d9706719
1542997168 HR buprenorphine 0.0075 MG/HR Transdermal SystemSCDc7d079fb-507f-436f-b794-2171b7d9706719
904870168 HR buprenorphine 0.01 MG/HR Transdermal SystemSCDc7d079fb-507f-436f-b794-2171b7d9706719
1432969168 HR buprenorphine 0.015 MG/HR Transdermal SystemSCDc7d079fb-507f-436f-b794-2171b7d9706719
904876168 HR buprenorphine 0.02 MG/HR Transdermal SystemSCDc7d079fb-507f-436f-b794-2171b7d9706719
904870buprenorphine 10 MCG/HR 7 Day Transdermal SystemSYc7d079fb-507f-436f-b794-2171b7d9706719
904870buprenorphine 10 MCG/HR Weekly Transdermal PatchSYc7d079fb-507f-436f-b794-2171b7d9706719
1432969buprenorphine 15 MCG/HR 7 Day Transdermal SystemSYc7d079fb-507f-436f-b794-2171b7d9706719
1432969buprenorphine 15 MCG/HR Weekly Transdermal PatchSYc7d079fb-507f-436f-b794-2171b7d9706719
904876buprenorphine 20 MCG/HR 7 Day Transdermal SystemSYc7d079fb-507f-436f-b794-2171b7d9706719
904876buprenorphine 20 MCG/HR Weekly Transdermal PatchSYc7d079fb-507f-436f-b794-2171b7d9706719
904880buprenorphine 5 MCG/HR 7 Day Transdermal SystemSYc7d079fb-507f-436f-b794-2171b7d9706719
904880buprenorphine 5 MCG/HR Weekly Transdermal PatchSYc7d079fb-507f-436f-b794-2171b7d9706719
1542997buprenorphine 7.5 MCG/HR 7 Day Transdermal PatchSYc7d079fb-507f-436f-b794-2171b7d9706719
1542997buprenorphine 7.5 MCG/HR 7 Day Transdermal SystemSYc7d079fb-507f-436f-b794-2171b7d9706719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1204-2692381204024 POUCH in 1 CARTON (69238-1204-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH4 pouch2020-04-200000-00-00NoNoCurrent