BUPRENORPHINE

Product NDC
58118-0502
11-digit product format
581180502
Labeler code
58118
Product ID
58118-0502_0e859e75-928c-e576-e063-6294a90a8421
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPRENORPHINE
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA207276
Marketing category
ANDA
Marketing start
2017-10-25
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207276-001BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27
A207276-002BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207276-001AB
A207276-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207276-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2017-03-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A207276-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2017-03-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207276-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207276-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207276-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207276-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207276-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207276-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207276-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207276-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207276-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207276-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207276-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207276-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207276-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207276-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207276-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207276-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207276-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207276-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207276-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207276-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207276-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207276-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207276-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207276-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207276-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207276-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207276-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207276-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207276-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207276-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207276-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207276-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207276-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207276-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207276-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207276-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207276-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207276-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207276-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207276-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
BUPRENORPHINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
56W8MW3EN1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351265Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2181e700-caa1-48c4-90ce-60fec053ba6aAvailable 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58118-0502-8BUPRENORPHINE30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0502BUPRENORPHINE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]2Current NDC, Legacy NDC, 1 package rows20240110_2181e700-caa1-48c4-90ce-60fec053ba6a.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5578cd5c-c860-6e8a-e063-6394a90a56c72026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackaa132031-9d12-45b4-81e0-4a58776613792026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5479b218-a388-2c3c-e063-6294a90a0e852026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepack966adb01-71b4-4e0b-bbc6-b83da9987aa22026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackbc5a7137-9e8f-438e-84d9-bdbf1db129982026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals LLCda90618a-5621-4b15-bc48-9dcc631418de2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackcd0a90c6-32cc-4114-8573-86ac85503bdf2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINEA-S Medication Solutionsbfb02ea5-22f2-432e-afc8-f1dbe2ea06142026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepacka7da638f-f590-4577-bff9-15a91c6e79172025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BuprenorphineBUPRENORPHINEAmerican Health Packaging8d38f7aa-da0b-40ad-b0d1-4284c71042ed2024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
BUPRENORPHINEBUPRENORPHINEClinical Solutions Wholesale, LLC2181e700-caa1-48c4-90ce-60fec053ba6a2024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276
ndc (product): 58118-0502
BUPRENORPHINEBUPRENORPHINEClinical Solutions Wholesale, LLC325532f0-276f-4689-97d6-cda879b4c7582024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207276
application number: ANDA207276

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351265buprenorphine HCl 8 MG Sublingual TabletPSN2181e700-caa1-48c4-90ce-60fec053ba6a2
351265buprenorphine 8 MG Sublingual TabletSCD2181e700-caa1-48c4-90ce-60fec053ba6a2
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY2181e700-caa1-48c4-90ce-60fec053ba6a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0502-85811805020830 TABLET in 1 BLISTER PACK (58118-0502-8) 30 tablet2022-10-070000-00-00NoNoCurrent