Buprenorphine

Product NDC
69238-1505
11-digit product format
692381505
Labeler code
69238
Product ID
69238-1505_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
7.5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211586-001BUPRENORPHINEBUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14
A211586-002BUPRENORPHINEBUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14
A211586-003BUPRENORPHINEBUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14
A211586-004BUPRENORPHINEBUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14
A211586-005BUPRENORPHINEBUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A211586-001AB
A211586-002AB
A211586-003AB
A211586-004AB
A211586-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211586-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211586-002BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211586-003BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211586-004BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211586-005BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-002BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-003BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-004BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-005BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211586-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211586-002BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211586-003BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211586-004BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211586-005BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-002BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-003BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-004BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-005BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-002BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-003BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-004BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-005BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-002BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-003BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-004BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-005BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-002BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-003BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-004BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-005BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-002BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-003BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-004BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-005BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2020-04-145bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211586-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211586-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211586-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211586-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211586-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211586-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211586-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211586-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211586-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211586-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211586-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211586-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211586-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211586-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211586-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211586-005AB15bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2020-12-22 03:56 UTC2020-12A211586-002CGT2020-10-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211586-002CGT2020-10-13c0c555d07b60…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE7.5 ug/h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
40D3SCR4GZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904870Internal RxNorm lookup
904876Internal RxNorm lookup
904880Internal RxNorm lookup
1432969Internal RxNorm lookup
1542997Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7d079fb-507f-436f-b794-2171b7d97067Available on FDA.report

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
69238-1505-2Buprenorphine4 in 1 CARTONPATCH, EXTENDED RELEASE419
69238-1505-2Buprenorphine1 in 1 POUCHPATCH, EXTENDED RELEASE119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1505-2EA - Each69238-1505a1a60839-6032-4209-a9b2-e30ad6d1868612020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1505BUPRENORPHINE PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]18Current NDC, Legacy NDC, 2 package rows20240316_c7d079fb-507f-436f-b794-2171b7d97067.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BuprenorphineBUPRENORPHINEAmneal Pharmaceuticals NY LLCc7d079fb-507f-436f-b794-2171b7d970672026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211586
application number: ANDA211586
ndc (product): 69238-1505

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
69238-1505-2692381505024 POUCH in 1 CARTON (69238-1505-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH4 pouch2020-04-200000-00-00NoNoCurrent