National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 01:05:20
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59011-752-04 | EA - Each | 59011-752 | 06c48e99-38e7-45b2-b67e-e697a6f8c487 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59011-752 | 59011-752-04 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021306-001 | BUTRANS | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 |
| N021306-002 | BUTRANS | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 |
| N021306-003 | BUTRANS | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 |
| N021306-004 | BUTRANS | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 |
| N021306-005 | BUTRANS | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021306-001 | AB |
| N021306-002 | AB |
| N021306-003 | AB |
| N021306-004 | AB |
| N021306-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021306-001 | BUTRANS | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021306-002 | BUTRANS | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021306-003 | BUTRANS | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021306-004 | BUTRANS | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021306-005 | BUTRANS | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-001 | BUTRANS | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-002 | BUTRANS | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-003 | BUTRANS | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-004 | BUTRANS | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-005 | BUTRANS | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-001 | BUTRANS | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-002 | BUTRANS | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-003 | BUTRANS | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-004 | BUTRANS | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-005 | BUTRANS | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-001 | BUTRANS | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-002 | BUTRANS | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-003 | BUTRANS | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-004 | BUTRANS | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-005 | BUTRANS | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-001 | BUTRANS | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-002 | BUTRANS | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-003 | BUTRANS | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-004 | BUTRANS | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-005 | BUTRANS | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-001 | BUTRANS | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-002 | BUTRANS | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-003 | BUTRANS | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-004 | BUTRANS | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-005 | BUTRANS | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-001 | BUTRANS | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-002 | BUTRANS | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-003 | BUTRANS | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-004 | BUTRANS | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-005 | BUTRANS | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-001 | BUTRANS | 5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-002 | BUTRANS | 10MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2010-06-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-003 | BUTRANS | 20MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD, RS | 2010-06-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-004 | BUTRANS | 15MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2013-07-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-005 | BUTRANS | 7.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | RLD | 2014-06-30 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021306-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021306-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021306-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021306-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021306-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021306-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021306-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021306-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021306-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021306-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021306-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021306-005 | AB | 1 | 03ed91905a0d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-22 03:56 UTC | 2020-12 | N021306-001 | M-250 | 2020-10-13 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021306-002 | M-250 | 2020-10-13 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021306-003 | M-250 | 2020-10-13 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021306-004 | M-250 | 2020-10-13 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021306-005 | M-250 | 2020-10-13 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021306-001 | M-250 | 2020-10-13 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021306-002 | M-250 | 2020-10-13 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021306-003 | M-250 | 2020-10-13 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021306-004 | M-250 | 2020-10-13 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021306-005 | M-250 | 2020-10-13 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Butrans | BUPRENORPHINE | Knoa Pharma LLC | 794aa355-66de-41b8-aedf-f2c40f6bc664 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 59011-752-04 59011075204 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.