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 02:52:24
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65250-266-20 | ML - Milliliter | 65250-266 | d9fc2b4c-b59b-4707-8e69-dc8e5f11ce45 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65250-266 | 65250-266-20 |
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 |
|---|---|---|---|---|---|---|---|
| N022496-001 | EXPAREL | BUPIVACAINE | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | |
| N022496-002 | EXPAREL | BUPIVACAINE | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022496-001 | 11033495 | 2041-01-22 | U-3182 | Drug product | 2021-07-30 |
| N022496-001 | 11179336 | 2041-01-22 | U-3250 | Drug product | 2021-11-30 |
| N022496-001 | 11278494 | 2041-01-22 | U-3250 | Drug product | 2022-04-04 |
| N022496-001 | 11304904 | 2041-01-22 | U-3346 | Drug product | 2022-04-21 |
| N022496-001 | 11311486 | 2041-01-22 | U-3250 | Drug product | 2022-04-27 |
| N022496-001 | 11357727 | 2041-01-22 | U-3380 | Drug product | 2022-06-16 |
| N022496-001 | 11426348 | 2041-01-22 | U-3380 | Drug product | 2022-09-02 |
| N022496-001 | 11452691 | 2041-01-22 | U-3439 | Drug product | 2022-10-04 |
| N022496-001 | 11819574 | 2041-01-22 | U-3250 | Drug product | 2023-12-06 |
| N022496-001 | 11819575 | 2041-01-22 | U-3250 | Drug product | 2023-12-06 |
| N022496-001 | 11925706 | 2041-01-22 | U-3380 | Drug product | 2024-03-15 |
| N022496-001 | 12144890 | 2041-01-22 | U-4033 | Drug product | 2024-11-20 |
| N022496-001 | 12151024 | 2041-01-22 | U-4037 | Drug product | 2024-11-26 |
| N022496-001 | 12296047 | 2041-01-22 | U-4184 | Drug product | 2025-05-20 |
| N022496-001 | 11931459 | 2042-03-17 | U-3839 | 2024-03-20 | |
| N022496-001 | 11931459 | 2042-03-17 | U-3840 | 2024-03-20 | |
| N022496-001 | 11918565 | 2043-02-02 | U-3841 | 2024-03-20 | |
| N022496-001 | 12226610 | 2043-02-02 | U-4148 | 2025-03-14 | |
| N022496-001 | 12226610 | 2043-02-02 | U-4149 | 2025-03-14 | |
| N022496-001 | 12226610 | 2043-02-02 | U-4150 | 2025-03-14 | |
| N022496-001 | 12156940 | 2044-07-02 | Drug product | 2024-12-03 | |
| N022496-001 | 12251468 | 2044-07-02 | U-4152 | Drug product | 2025-03-21 |
| N022496-001 | 12318483 | 2044-07-02 | U-4152 | 2025-06-11 | |
| N022496-001 | 12370142 | 2044-07-02 | U-4152 | Drug product | 2025-08-07 |
| N022496-002 | 11033495 | 2041-01-22 | U-3182 | Drug product | 2021-07-30 |
| N022496-002 | 11179336 | 2041-01-22 | U-3250 | Drug product | 2021-11-30 |
| N022496-002 | 11278494 | 2041-01-22 | U-3250 | Drug product | 2022-04-04 |
| N022496-002 | 11304904 | 2041-01-22 | U-3346 | Drug product | 2022-04-21 |
| N022496-002 | 11311486 | 2041-01-22 | U-3250 | Drug product | 2022-04-27 |
| N022496-002 | 11357727 | 2041-01-22 | U-3380 | Drug product | 2022-06-16 |
| N022496-002 | 11426348 | 2041-01-22 | U-3380 | Drug product | 2022-09-02 |
| N022496-002 | 11452691 | 2041-01-22 | U-3439 | Drug product | 2022-10-04 |
| N022496-002 | 11819574 | 2041-01-22 | U-3250 | Drug product | 2023-12-06 |
| N022496-002 | 11819575 | 2041-01-22 | U-3250 | Drug product | 2023-12-06 |
| N022496-002 | 11925706 | 2041-01-22 | U-3380 | Drug product | 2024-03-15 |
| N022496-002 | 12144890 | 2041-01-22 | U-4033 | Drug product | 2024-11-20 |
| N022496-002 | 12151024 | 2041-01-22 | U-4037 | Drug product | 2024-11-26 |
| N022496-002 | 12296047 | 2041-01-22 | U-4184 | Drug product | 2025-05-20 |
| N022496-002 | 11931459 | 2042-03-17 | U-3839 | 2024-03-20 | |
| N022496-002 | 11931459 | 2042-03-17 | U-3840 | 2024-03-20 | |
| N022496-002 | 11918565 | 2043-02-02 | U-3841 | 2024-03-20 | |
| N022496-002 | 12226610 | 2043-02-02 | U-4148 | 2025-03-14 | |
| N022496-002 | 12226610 | 2043-02-02 | U-4149 | 2025-03-14 | |
| N022496-002 | 12226610 | 2043-02-02 | U-4150 | 2025-03-14 | |
| N022496-002 | 12156940 | 2044-07-02 | Drug product | 2024-12-03 | |
| N022496-002 | 12251468 | 2044-07-02 | U-4152 | Drug product | 2025-03-21 |
| N022496-002 | 12318483 | 2044-07-02 | U-4152 | 2025-06-11 | |
| N022496-002 | 12370142 | 2044-07-02 | U-4152 | Drug product | 2025-08-07 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N022496-001 | I-929 | 2026-11-09 |
| N022496-002 | I-929 | 2026-11-09 |
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 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AP | RLD, RS | 2011-10-28 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022496-001 | EXPAREL | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022496-002 | EXPAREL | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | RLD, RS | 2011-10-28 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N022496-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022496-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022496-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022496-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022496-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022496-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022496-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022496-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022496-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022496-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022496-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022496-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022496-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022496-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022496-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022496-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022496-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022496-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022496-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022496-002 | AP | 1 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11033495 | 2041-01-22 | U-3182 | Drug product | 2021-07-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11179336 | 2041-01-22 | U-3250 | Drug product | 2021-11-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11278494 | 2041-01-22 | U-3250 | Drug product | 2022-04-04 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11304904 | 2041-01-22 | U-3346 | Drug product | 2022-04-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11311486 | 2041-01-22 | U-3250 | Drug product | 2022-04-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11357727 | 2041-01-22 | U-3380 | Drug product | 2022-06-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11426348 | 2041-01-22 | U-3380 | Drug product | 2022-09-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11452691 | 2041-01-22 | U-3439 | Drug product | 2022-10-04 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11819574 | 2041-01-22 | U-3250 | Drug product | 2023-12-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11819575 | 2041-01-22 | U-3250 | Drug product | 2023-12-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11925706 | 2041-01-22 | U-3380 | Drug product | 2024-03-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12144890 | 2041-01-22 | U-4033 | Drug product | 2024-11-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12151024 | 2041-01-22 | U-4037 | Drug product | 2024-11-26 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12296047 | 2041-01-22 | U-4184 | Drug product | 2025-05-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11931459 | 2042-03-17 | U-3839 | 2024-03-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11931459 | 2042-03-17 | U-3840 | 2024-03-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 11918565 | 2043-02-02 | U-3841 | 2024-03-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12226610 | 2043-02-02 | U-4148 | 2025-03-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12226610 | 2043-02-02 | U-4149 | 2025-03-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12226610 | 2043-02-02 | U-4150 | 2025-03-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12156940 | 2044-07-02 | Drug product | 2024-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12251468 | 2044-07-02 | U-4152 | Drug product | 2025-03-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12318483 | 2044-07-02 | U-4152 | 2025-06-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | 12370142 | 2044-07-02 | U-4152 | Drug product | 2025-08-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11033495 | 2041-01-22 | U-3182 | Drug product | 2021-07-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11179336 | 2041-01-22 | U-3250 | Drug product | 2021-11-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11278494 | 2041-01-22 | U-3250 | Drug product | 2022-04-04 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11304904 | 2041-01-22 | U-3346 | Drug product | 2022-04-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11311486 | 2041-01-22 | U-3250 | Drug product | 2022-04-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11357727 | 2041-01-22 | U-3380 | Drug product | 2022-06-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11426348 | 2041-01-22 | U-3380 | Drug product | 2022-09-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11452691 | 2041-01-22 | U-3439 | Drug product | 2022-10-04 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11819574 | 2041-01-22 | U-3250 | Drug product | 2023-12-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11819575 | 2041-01-22 | U-3250 | Drug product | 2023-12-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11925706 | 2041-01-22 | U-3380 | Drug product | 2024-03-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 12144890 | 2041-01-22 | U-4033 | Drug product | 2024-11-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 12151024 | 2041-01-22 | U-4037 | Drug product | 2024-11-26 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 12296047 | 2041-01-22 | U-4184 | Drug product | 2025-05-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11931459 | 2042-03-17 | U-3840 | 2024-03-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | 11931459 | 2042-03-17 | U-3839 | 2024-03-20 | 84e616aacf4f… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022496-001 | I-929 | 2026-11-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022496-002 | I-929 | 2026-11-09 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022496-001 | I-929 | 2026-11-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022496-002 | I-929 | 2026-11-09 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022496-001 | I-929 | 2026-11-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022496-002 | I-929 | 2026-11-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022496-001 | I-929 | 2026-11-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022496-002 | I-929 | 2026-11-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022496-001 | I-929 | 2026-11-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022496-002 | I-929 | 2026-11-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022496-001 | I-929 | 2026-11-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022496-002 | I-929 | 2026-11-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022496-001 | I-929 | 2026-11-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022496-002 | I-929 | 2026-11-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022496-001 | NPP | 2024-03-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022496-001 | I-929 | 2026-11-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022496-002 | NPP | 2024-03-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022496-002 | I-929 | 2026-11-09 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022496-001 | NPP | 2024-03-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022496-001 | I-929 | 2026-11-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022496-002 | NPP | 2024-03-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022496-002 | I-929 | 2026-11-09 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022496-001 | NPP | 2024-03-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022496-001 | I-929 | 2026-11-09 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022496-002 | NPP | 2024-03-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022496-002 | I-929 | 2026-11-09 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022496-001 | NPP | 2024-03-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022496-001 | I-929 | 2026-11-09 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022496-002 | NPP | 2024-03-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022496-002 | I-929 | 2026-11-09 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022496-001 | NPP | 2024-03-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022496-001 | I-929 | 2026-11-09 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022496-002 | NPP | 2024-03-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022496-002 | I-929 | 2026-11-09 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022496-001 | NPP | 2024-03-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022496-001 | I-929 | 2026-11-09 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022496-002 | NPP | 2024-03-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022496-002 | I-929 | 2026-11-09 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022496-001 | NPP | 2024-03-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022496-001 | I-929 | 2026-11-09 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| EXPAREL | BUPIVACAINE | Pacira Pharmaceuticals, Inc. | bb5a9e59-0f51-11df-8a39-0800200c9a66 | 2025-12-12 | Warnings, Adverse reactions | 65250-266-20 65250026620 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.