BUPRENORPHINE AND NALOXONE
- Product NDC
- 0781-7216
- Requested package NDC
- 0781-7216-64
- 11-digit product format
- 007817216
- Labeler code
- 0781
- Product ID
- 0781-7216_a6b7a3db-91a1-4334-9fea-63e33e845cfa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride, naloxone hydrochloride
- Dosage form
- FILM, SOLUBLE
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Indivior Inc.
- Application
- NDA022410
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-02-19
- Marketing end
- 2021-04-30
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 2 mg/1; mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 package | package | 0781-7216 | 0781-7216-64 | D | Discontinued by firm | 2026-08-03 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022410-001 | SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 |
| N022410-002 | SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 |
| N022410-003 | SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 |
| N022410-004 | SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022410-001 | AB |
| N022410-002 | AB |
| N022410-003 | AB |
| N022410-004 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022410-001 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 |
| N022410-001 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 |
| N022410-001 | 8475832 | 2030-03-26 | U-1411 | Drug product | 2013-07-03 |
| N022410-002 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 |
| N022410-002 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 |
| N022410-002 | 8475832 | 2030-03-26 | U-1411 | Drug product | |
| N022410-003 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 |
| N022410-003 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 |
| N022410-003 | 8475832 | 2030-03-26 | U-1411 | Drug product | |
| N022410-004 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 |
| N022410-004 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 |
| N022410-004 | 8475832 | 2030-03-26 | U-1411 | Drug product |
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 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022410-001 | SUBOXONE | EQ 2MG BASE;EQ 0.5MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022410-002 | SUBOXONE | EQ 8MG BASE;EQ 2MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2010-08-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022410-003 | SUBOXONE | EQ 4MG BASE;EQ 1MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD | 2012-08-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022410-004 | SUBOXONE | EQ 12MG BASE;EQ 3MG BASE | FILM / BUCCAL, SUBLINGUAL | AB | RLD, RS | 2012-08-10 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022410-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022410-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022410-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022410-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022410-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022410-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022410-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022410-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022410-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022410-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022410-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022410-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022410-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022410-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022410-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022410-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022410-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022410-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022410-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022410-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022410-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022410-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022410-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022410-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022410-004 | AB | 1 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022410-001 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-001 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-001 | 8475832 | 2030-03-26 | U-1411 | Drug product | 2013-07-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-002 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-002 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-002 | 8475832 | 2030-03-26 | U-1411 | Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-003 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-003 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-003 | 8475832 | 2030-03-26 | U-1411 | Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-004 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-004 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022410-004 | 8475832 | 2030-03-26 | U-1411 | Drug product | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-001 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-001 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-001 | 8475832 | 2030-03-26 | U-1411 | Drug product | 2013-07-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-002 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-002 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-002 | 8475832 | 2030-03-26 | U-1411 | Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-003 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-003 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-003 | 8475832 | 2030-03-26 | U-1411 | Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-004 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-004 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022410-004 | 8475832 | 2030-03-26 | U-1411 | Drug product | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-001 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-001 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-001 | 8475832 | 2030-03-26 | U-1411 | Drug product | 2013-07-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-002 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-002 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-002 | 8475832 | 2030-03-26 | U-1411 | Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-003 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-003 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-003 | 8475832 | 2030-03-26 | U-1411 | Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-004 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-004 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022410-004 | 8475832 | 2030-03-26 | U-1411 | Drug product | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-001 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-001 | 9687454 | 2029-08-07 | U-1464 | Drug product | 2017-07-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-001 | 8475832 | 2030-03-26 | U-1411 | Drug product | 2013-07-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022410-002 | 11135216 | 2029-08-07 | U-3111 | Drug product | 2021-10-21 | fd3edfee7708… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-7216-06 | EA - Each | 0781-7216 | c660ea43-9460-4969-b54c-1c715912e4ab | 1 | 2019-07-02 |
| 0781-7216-64 | EA - Each | 0781-7216 | 6ce94f64-6daa-4aa0-9ea0-de7a32ea6cb6 | 1 | 2019-03-12 |
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 |
|---|---|---|---|---|---|---|
| Suboxone | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE | INDIVIOR INC. | 8a5edcf9-828c-4f97-b671-268ab13a8ecd | 2025-12-22 | Warnings, Adverse reactions | 022410 NDA022410 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0781-7216-64 | 00781721664 | 30 POUCH in 1 CARTON (0781-7216-64) > 1 FILM, SOLUBLE in 1 POUCH (0781-7216-06) | 30 pouch | 2019-02-19 | 2021-04-30 | No | No | Current |