Buprenorphine HCl

Product NDC
70518-2014
Requested package NDC
70518-2014-0
11-digit product format
705182014
Labeler code
70518
Product ID
70518-2014_498bf1a2-fabc-0a31-e063-6294a90a6e94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine HCl
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
REMEDYREPACK INC.
Application
ANDA078633
Marketing category
ANDA
Marketing start
2019-04-12
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
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-201470518-2014-0DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
A078633-001BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08
A078633-002BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078633-001AB
A078633-002AB

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 UTC2026-02A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078633-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2009-10-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A078633-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALABRS2009-10-08782e0a99824c…

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 UTC2026-02A078633-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078633-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078633-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078633-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078633-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078633-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078633-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078633-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078633-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078633-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078633-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078633-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078633-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078633-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078633-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078633-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078633-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078633-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078633-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078633-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078633-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078633-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078633-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078633-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078633-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078633-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078633-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078633-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078633-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078633-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078633-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078633-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078633-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078633-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078633-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078633-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078633-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078633-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078633-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078633-002AB1782e0a99824c…

Additional Listing Data#

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

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
69a647c0-bc09-4ee2-aeb3-ef286caf25e5Available 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
70518-2014-0Buprenorphine HCl30 in 1 BLISTER PACKTABLET3017
70518-2014-1Buprenorphine HCl60 in 1 BOTTLE, PLASTICTABLET6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2014-0EA - Each70518-201469339bdd-9555-4c35-87d3-2ab025a9e63712026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2014BUPRENORPHINE HCL TABLET [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 2 package rows20250306_69a647c0-bc09-4ee2-aeb3-ef286caf25e5.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.e1aac2bb-cb83-46cb-9a29-502a620106672026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633
BuprenorphineBUPRENORPHINEMajor Pharmaceuticalsdba586f9-e3f2-4b9c-849b-907c81a5a0ef2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.69a647c0-bc09-4ee2-aeb3-ef286caf25e52026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633
ndc (package): 70518-2014-0
ndc (product): 70518-2014
ndc11 (package): 70518201400
BuprenorphineBUPRENORPHINEHikma Pharmaceuticals USA Inc.1bf8b35a-b769-465c-a2f8-099868dfcd2f2026-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633
Buprenorphine HClBUPRENORPHINE HCLRedpharm Drug301eaed5-8499-ad95-e063-6294a90a58f52025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633
Buprenorphine HClBUPRENORPHINE HCLBryant Ranch Prepackd5a8c41e-413e-4d48-9739-d158e5681dd02025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633
Buprenorphine Sublingual C-IIIBUPRENORPHINE SUBLINGUAL C-IIIDirect_Rx22412030-a641-28d8-e063-6294a90a2fef2024-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633
Buprenorphine Sublingual C-IIIBUPRENORPHINE SUBLINGUAL C-IIIDirect_Rx248524c6-4c8b-a450-e063-6394a90a81ef2024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633
Buprenorphine HClBUPRENORPHINE HCLClinical Solutions Wholesale, LLC3a7418a2-bd6e-4082-b0fe-a5498e7b944a2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078633
application number: ANDA078633

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351265buprenorphine HCl 8 MG Sublingual TabletPSN69a647c0-bc09-4ee2-aeb3-ef286caf25e517
351265buprenorphine 8 MG Sublingual TabletSCD69a647c0-bc09-4ee2-aeb3-ef286caf25e517
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY69a647c0-bc09-4ee2-aeb3-ef286caf25e517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2014-07051820140030 TABLET in 1 BLISTER PACK (70518-2014-0) 30 tablet2019-04-120000-00-00NoNoCurrent