FDA.reportPublic FDA data

Buprenorphine

Product NDC
55700-579
Requested package NDC
55700-579-04
11-digit product format
557000579
Labeler code
55700
Product ID
55700-579_c5b43359-4dae-4292-a2ee-5f57813d7505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
NDA021306
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-01-12
Marketing end
0000-00-00
Substance
BUPRENORPHINE
Active strength
5 ug/h
Pharmacologic classes
Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-57955700-579-04DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
N021306-001BUTRANSBUPRENORPHINE5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-30
N021306-002BUTRANSBUPRENORPHINE10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-30
N021306-003BUTRANSBUPRENORPHINE20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-30
N021306-004BUTRANSBUPRENORPHINE15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-25
N021306-005BUTRANSBUPRENORPHINE7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021306-001AB
N021306-002AB
N021306-003AB
N021306-004AB
N021306-005AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021306-001BUTRANS5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021306-002BUTRANS10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021306-003BUTRANS20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021306-004BUTRANS15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021306-005BUTRANS7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-001BUTRANS5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-002BUTRANS10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-003BUTRANS20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-004BUTRANS15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-005BUTRANS7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021306-001BUTRANS5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021306-002BUTRANS10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021306-003BUTRANS20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021306-004BUTRANS15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021306-005BUTRANS7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-001BUTRANS5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-002BUTRANS10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-003BUTRANS20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-004BUTRANS15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-005BUTRANS7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-001BUTRANS5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-002BUTRANS10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-003BUTRANS20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-004BUTRANS15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-005BUTRANS7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-001BUTRANS5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-002BUTRANS10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-003BUTRANS20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-004BUTRANS15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-005BUTRANS7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-001BUTRANS5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-002BUTRANS10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-003BUTRANS20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-004BUTRANS15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-005BUTRANS7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-001BUTRANS5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-002BUTRANS10MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2010-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-003BUTRANS20MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS2010-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-004BUTRANS15MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2013-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-005BUTRANS7.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD2014-06-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021306-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021306-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021306-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021306-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021306-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021306-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021306-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021306-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021306-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021306-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021306-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021306-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021306-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021306-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021306-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021306-005AB15bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2020-12-22 03:56 UTC2020-12N021306-001M-2502020-10-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021306-002M-2502020-10-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021306-003M-2502020-10-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021306-004M-2502020-10-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021306-005M-2502020-10-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021306-001M-2502020-10-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021306-002M-2502020-10-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021306-003M-2502020-10-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021306-004M-2502020-10-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021306-005M-2502020-10-13c0c555d07b60…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-579-04EA - Each55700-57927d4e2fc-aca3-4411-9182-92105131ca7912018-02-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BuprenorphineBUPRENORPHINERhodes Pharmaceuticals LLC2738feae-316e-426f-971c-5f142ac01b602026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021306
application number: NDA021306
ButransBUPRENORPHINEKnoa Pharma LLC794aa355-66de-41b8-aedf-f2c40f6bc6642026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021306
application number: NDA021306

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-579-04557000579044 POUCH in 1 CARTON (55700-579-04) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH4 pouch2018-01-120000-00-00NoNoCurrent