buprenorphine transdermal system

Product NDC
47781-419
11-digit product format
477810419
Labeler code
47781
Product ID
47781-419_7f83c8aa-7590-e2fe-4998-55323eadd112
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Alvogen Inc.
Application
ANDA207490
Marketing category
ANDA
Marketing start
2022-05-17
Marketing end
2027-01-31
Substance
BUPRENORPHINE
Active strength
15 ug/h
Pharmacologic classes
Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
No
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
A207490-001BUPRENORPHINEBUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17
A207490-002BUPRENORPHINEBUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17
A207490-003BUPRENORPHINEBUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17
A207490-004BUPRENORPHINEBUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17
A207490-005BUPRENORPHINEBUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A207490-001AB
A207490-002AB
A207490-003AB
A207490-004AB

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 4 · 139 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207490-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207490-002BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207490-003BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207490-004BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207490-005BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-002BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-003BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-004BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-005BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207490-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207490-002BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207490-003BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207490-004BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207490-005BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-002BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-003BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-004BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-005BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-002BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-003BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-004BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-005BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-002BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-003BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-004BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-005BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-002BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-003BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-004BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-005BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-001BUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-002BUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-003BUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-004BUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2022-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-005BUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMAL2023-03-215bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207490-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207490-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207490-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207490-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207490-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207490-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207490-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207490-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207490-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207490-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207490-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207490-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207490-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207490-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207490-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207490-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207490-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207490-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207490-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207490-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207490-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207490-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
buprenorphine transdermal system

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE15 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 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
315284b8-32ab-d34a-ea02-f501c6131bccAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-419-04buprenorphine transdermal system4 in 1 CARTONPATCH, EXTENDED RELEASE44
47781-419-11buprenorphine transdermal system168 h in 1 PATCHPATCH, EXTENDED RELEASE1684
47781-419-11buprenorphine transdermal system1 in 1 POUCHPATCH, EXTENDED RELEASE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-419-04EA - Each47781-4199582def1-48eb-4cc7-81e7-be6f0a62120d12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-419BUPRENORPHINE TRANSDERMAL SYSTEM (BUPRENORPHINE) PATCH, EXTENDED RELEASE [ALVOGEN INC.]3Current NDC, Legacy NDC, 3 package rows20240316_315284b8-32ab-d34a-ea02-f501c6131bcc.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
buprenorphine transdermal systemBUPRENORPHINEAlvogen Inc.315284b8-32ab-d34a-ea02-f501c6131bcc2025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207490
application number: ANDA207490
ndc (product): 47781-419

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904870buprenorphine 10 MCG/HR 7 Day Transdermal SystemPSN315284b8-32ab-d34a-ea02-f501c6131bcc4
1432969buprenorphine 15 MCG/HR 7 Day Transdermal SystemPSN315284b8-32ab-d34a-ea02-f501c6131bcc4
904876buprenorphine 20 MCG/HR 7 Day Transdermal SystemPSN315284b8-32ab-d34a-ea02-f501c6131bcc4
904880buprenorphine 5 MCG/HR 7 Day Transdermal SystemPSN315284b8-32ab-d34a-ea02-f501c6131bcc4
904880168 HR buprenorphine 0.005 MG/HR Transdermal SystemSCD315284b8-32ab-d34a-ea02-f501c6131bcc4
904870168 HR buprenorphine 0.01 MG/HR Transdermal SystemSCD315284b8-32ab-d34a-ea02-f501c6131bcc4
1432969168 HR buprenorphine 0.015 MG/HR Transdermal SystemSCD315284b8-32ab-d34a-ea02-f501c6131bcc4
904876168 HR buprenorphine 0.02 MG/HR Transdermal SystemSCD315284b8-32ab-d34a-ea02-f501c6131bcc4
904870buprenorphine 10 MCG/HR 7 Day Transdermal SystemSY315284b8-32ab-d34a-ea02-f501c6131bcc4
904870buprenorphine 10 MCG/HR Weekly Transdermal PatchSY315284b8-32ab-d34a-ea02-f501c6131bcc4
1432969buprenorphine 15 MCG/HR 7 Day Transdermal SystemSY315284b8-32ab-d34a-ea02-f501c6131bcc4
1432969buprenorphine 15 MCG/HR Weekly Transdermal PatchSY315284b8-32ab-d34a-ea02-f501c6131bcc4
904876buprenorphine 20 MCG/HR 7 Day Transdermal SystemSY315284b8-32ab-d34a-ea02-f501c6131bcc4
904876buprenorphine 20 MCG/HR Weekly Transdermal PatchSY315284b8-32ab-d34a-ea02-f501c6131bcc4
904880buprenorphine 5 MCG/HR 7 Day Transdermal SystemSY315284b8-32ab-d34a-ea02-f501c6131bcc4
904880buprenorphine 5 MCG/HR Weekly Transdermal PatchSY315284b8-32ab-d34a-ea02-f501c6131bcc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-419-04477810419044 POUCH in 1 CARTON (47781-419-04) / 1 PATCH in 1 POUCH (47781-419-11) / 168 h in 1 PATCH4 pouch2022-08-292027-01-31NoNoCurrent
47781-419-1147781041911168 h in 1 PATCH168 hHistorical