buprenorphine hydrochloride
- Product NDC
- 0121-2038
- 11-digit product format
- 001212038
- Labeler code
- 0121
- Product ID
- 0121-2038_2c22b6ad-acee-4045-b5c5-025afe061b79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
- Application
- ANDA090622
- Marketing category
- ANDA
- Marketing start
- 2023-10-12
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090622-001 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | |
| A090622-002 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090622-001 | AB |
| A090622-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090622-001 | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090622-002 | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET / SUBLINGUAL | AB | 2010-09-24 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090622-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090622-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090622-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090622-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090622-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090622-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090622-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090622-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090622-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090622-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090622-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090622-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090622-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090622-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090622-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090622-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090622-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090622-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090622-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090622-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090622-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090622-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090622-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090622-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090622-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090622-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090622-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090622-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090622-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090622-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090622-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090622-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090622-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090622-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090622-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090622-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090622-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090622-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090622-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090622-002 | AB | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- buprenorphine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 56W8MW3EN1 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 442831cf-9636-433a-9a12-e9a8cd31f72a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-2038-30 | buprenorphine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-2038-30 | EA - Each | 0121-2038 | 50b48b86-11c5-4d87-ae0c-47259970d45b | 1 | 2023-10-16 |
DailyMed Dashboard NDC Coverage#
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 hydrochloride | BUPRENORPHINE HYDROCHLORIDE | REMEDYREPACK INC. | 11686845-f5fd-4e96-8a4f-9b132bf48840 | 2026-07-07 | Warnings, Adverse reactions | 090622 ANDA090622 |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 442831cf-9636-433a-9a12-e9a8cd31f72a | 2026-02-28 | Warnings, Adverse reactions | 090622 ANDA090622 0121-2038 |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | A-S Medication Solutions | c1398d85-d4bb-4426-8ecf-a50400910d81 | 2025-05-28 | Warnings, Adverse reactions | 090622 ANDA090622 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351264 | buprenorphine HCl 2 MG Sublingual Tablet | PSN | 442831cf-9636-433a-9a12-e9a8cd31f72a | 6 |
| 351265 | buprenorphine HCl 8 MG Sublingual Tablet | PSN | 442831cf-9636-433a-9a12-e9a8cd31f72a | 6 |
| 351264 | buprenorphine 2 MG Sublingual Tablet | SCD | 442831cf-9636-433a-9a12-e9a8cd31f72a | 6 |
| 351265 | buprenorphine 8 MG Sublingual Tablet | SCD | 442831cf-9636-433a-9a12-e9a8cd31f72a | 6 |
| 351264 | buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet | SY | 442831cf-9636-433a-9a12-e9a8cd31f72a | 6 |
| 351265 | buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet | SY | 442831cf-9636-433a-9a12-e9a8cd31f72a | 6 |
| 351265 | buprenorphine HCl 8 MG Sublingual Tablet | PSN | 11686845-f5fd-4e96-8a4f-9b132bf48840 | 1 |
| 351265 | buprenorphine HCl 8 MG Sublingual Tablet | PSN | c1398d85-d4bb-4426-8ecf-a50400910d81 | 1 |
| 351265 | buprenorphine 8 MG Sublingual Tablet | SCD | 11686845-f5fd-4e96-8a4f-9b132bf48840 | 1 |
| 351265 | buprenorphine 8 MG Sublingual Tablet | SCD | c1398d85-d4bb-4426-8ecf-a50400910d81 | 1 |
| 351265 | buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet | SY | 11686845-f5fd-4e96-8a4f-9b132bf48840 | 1 |
| 351265 | buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet | SY | c1398d85-d4bb-4426-8ecf-a50400910d81 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0121-2038-30 | 00121203830 | 30 TABLET in 1 BOTTLE (0121-2038-30) | 30 tablet | 2023-10-12 | No | No | Current |