buprenorphine transdermal system
- Product NDC
- 58064-408
- 11-digit product format
- 580640408
- Labeler code
- 58064
- Product ID
- 58064-408_45afa585-2243-cf7b-e063-6394a90a74e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- LTS Therapy Systems, LLC
- Application
- ANDA207490
- Marketing category
- ANDA
- Marketing start
- 2022-05-17
- Substance
- BUPRENORPHINE
- Active strength
- 20 ug/h
- 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 |
|---|---|---|---|---|---|---|---|
| A207490-001 | BUPRENORPHINE | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | |
| A207490-002 | BUPRENORPHINE | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | |
| A207490-003 | BUPRENORPHINE | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | |
| A207490-004 | BUPRENORPHINE | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | |
| A207490-005 | BUPRENORPHINE | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207490-001 | AB |
| A207490-002 | AB |
| A207490-003 | AB |
| A207490-004 | 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 | A207490-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207490-002 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207490-003 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207490-004 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207490-005 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-002 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-003 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-004 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-005 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207490-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207490-002 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207490-003 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207490-004 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207490-005 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-002 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-003 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-004 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-005 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-002 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-003 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-004 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-005 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-002 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-003 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-004 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-005 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-002 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-003 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-004 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-005 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-001 | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-002 | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-003 | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-004 | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2022-05-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-005 | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2023-03-21 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207490-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207490-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207490-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207490-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207490-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207490-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207490-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207490-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207490-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207490-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207490-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207490-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207490-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207490-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207490-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207490-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207490-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207490-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207490-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207490-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207490-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207490-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- buprenorphine transdermal system
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE | 20 ug/h |
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 transdermal system | BUPRENORPHINE | Alvogen Inc. | 315284b8-32ab-d34a-ea02-f501c6131bcc | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | 207490 ANDA207490 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58064-408-04 | 58064040804 | 4 POUCH in 1 CARTON (58064-408-04) / 1 PATCH in 1 POUCH (58064-408-11) / 168 h in 1 PATCH | 4 pouch | 2022-08-29 | 0000-00-00 | No | No | Current |