Buprenorphine HCl

Product NDC
55700-302
Requested package NDC
55700-302-30
11-digit product format
557000302
Labeler code
55700
Product ID
55700-302_d1484609-62f8-4b1e-8864-969b452cfb46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine HCl
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078633
Marketing category
ANDA
Marketing start
2009-10-08
Marketing end
0000-00-00
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage55700-30255700-302-30DDiscontinued 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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-302-30EA - Each55700-3028730b83d-60d1-417e-b9db-5dd6aa73fdfe12016-06-14

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-302-305570003023030 TABLET in 1 BOTTLE (55700-302-30) 30 tablet2015-09-230000-00-00NoNoCurrent