buprenorphine hydrochloride
- Product NDC
- 63629-7126
- 11-digit product format
- 636297126
- Labeler code
- 63629
- Product ID
- 63629-7126_3e09672a-40d7-4e56-b625-15d488f711d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090622
- Marketing category
- ANDA
- Marketing start
- 2010-09-24
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 8 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63629-7126 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 63629-7126 | 63629-7126-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-7126 | 63629-7126-2 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-7126 | 63629-7126-3 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-7126 | 63629-7126-4 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-7126 | 63629-7126-5 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-7126 | 63629-7126-6 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-7126 | 63629-7126-7 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-7126 | 63629-7126-8 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63629-7126 | 63629-7126-9 | D | Discontinued by firm | 2026-08-17 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-7126-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-7126-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-7126-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-7126-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-7126-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-7126-9 | cdf11ea48f46… | ba0047e9e063… |
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… |
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 |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | A-S Medication Solutions | c1398d85-d4bb-4426-8ecf-a50400910d81 | 2025-05-28 | Warnings, Adverse reactions | 090622 ANDA090622 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-7126-1 | 63629712601 | 90 TABLET in 1 BOTTLE (63629-7126-1) | 90 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63629-7126-2 | 63629712602 | 60 TABLET in 1 BOTTLE (63629-7126-2) | 60 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63629-7126-3 | 63629712603 | 30 TABLET in 1 BOTTLE (63629-7126-3) | 30 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63629-7126-4 | 63629712604 | 20 TABLET in 1 BOTTLE (63629-7126-4) | 20 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63629-7126-5 | 63629712605 | 7 TABLET in 1 BOTTLE (63629-7126-5) | 7 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63629-7126-6 | 63629712606 | 28 TABLET in 1 BOTTLE (63629-7126-6) | 28 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63629-7126-7 | 63629712607 | 1 TABLET in 1 BOTTLE (63629-7126-7) | 1 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63629-7126-8 | 63629712608 | 12 TABLET in 1 BOTTLE (63629-7126-8) | 12 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63629-7126-9 | 63629712609 | 14 TABLET in 1 BOTTLE (63629-7126-9) | 14 tablet | 2017-04-26 | 0000-00-00 | No | No | Current |