BUPRENORPHINE
- Product NDC
- 58118-0501
- 11-digit product format
- 581180501
- Labeler code
- 58118
- Product ID
- 58118-0501_0e85a5c9-76a8-f621-e063-6394a90a8782
- 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
- 2 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207276-001 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | |
| A207276-002 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207276-001 | AB |
| A207276-002 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207276-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207276-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2017-03-27 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207276-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207276-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207276-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207276-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207276-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207276-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207276-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207276-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207276-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207276-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207276-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207276-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207276-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207276-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207276-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207276-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207276-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207276-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207276-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207276-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207276-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207276-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207276-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207276-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207276-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207276-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207276-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A207276-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207276-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207276-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207276-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207276-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207276-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207276-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207276-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207276-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207276-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207276-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207276-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A207276-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUPRENORPHINE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 56W8MW3EN1 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 351264 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 325532f0-276f-4689-97d6-cda879b4c758 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58118-0501-8 | BUPRENORPHINE | 30 in 1 BLISTER PACK | TABLET | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58118-0501 | BUPRENORPHINE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240110_325532f0-276f-4689-97d6-cda879b4c758.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5578cd5c-c860-6e8a-e063-6394a90a56c7 | 2026-06-30 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | aa132031-9d12-45b4-81e0-4a5877661379 | 2026-06-29 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5479b218-a388-2c3c-e063-6294a90a0e85 | 2026-06-17 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | 966adb01-71b4-4e0b-bbc6-b83da9987aa2 | 2026-06-16 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | bc5a7137-9e8f-438e-84d9-bdbf1db12998 | 2026-06-03 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Rhodes Pharmaceuticals LLC | da90618a-5621-4b15-bc48-9dcc631418de | 2026-05-04 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | cd0a90c6-32cc-4114-8573-86ac85503bdf | 2026-04-03 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | A-S Medication Solutions | bfb02ea5-22f2-432e-afc8-f1dbe2ea0614 | 2026-02-06 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | a7da638f-f590-4577-bff9-15a91c6e7917 | 2025-07-29 | Warnings, Adverse reactions | 207276 ANDA207276 |
| Buprenorphine | BUPRENORPHINE | American Health Packaging | 8d38f7aa-da0b-40ad-b0d1-4284c71042ed | 2024-12-30 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 2181e700-caa1-48c4-90ce-60fec053ba6a | 2024-01-09 | Warnings, Adverse reactions | 207276 ANDA207276 |
| BUPRENORPHINE | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 325532f0-276f-4689-97d6-cda879b4c758 | 2024-01-09 | Warnings, Adverse reactions | 207276 ANDA207276 58118-0501 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351264 | buprenorphine HCl 2 MG Sublingual Tablet | PSN | 325532f0-276f-4689-97d6-cda879b4c758 | 2 |
| 351264 | buprenorphine 2 MG Sublingual Tablet | SCD | 325532f0-276f-4689-97d6-cda879b4c758 | 2 |
| 351264 | buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet | SY | 325532f0-276f-4689-97d6-cda879b4c758 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58118-0501-8 | 58118050108 | 30 TABLET in 1 BLISTER PACK (58118-0501-8) | 30 tablet | 2017-10-25 | 0000-00-00 | No | No | Current |