Boxed warning
Product Label
POSIMIR (Bupivacaine Solution) 660 mg/5mL (132 mg/mL)
- Manufacturer
- Renaissance Lakewood, LLC
- Effective date
- 2022-12-13
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:44:35
Label at a glance#
ProductPOSIMIR
Active ingredientBUPIVACAINE
Label structure2 sections
Label contents#
Full prescribing information#
BOXED WARNING SECTION
Product Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Vial
Products#
Every source-derived product name is available through these pages.
- POSIMIR
- Bupivacaine
- BENZYL ALCOHOL
- SUCROSE ACETATE ISOBUTYRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49396-6601 | 49396-6601-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| SUCROSE ACETATE ISOBUTYRATE | H5KI1C3YTV | IACT |
| BUPIVACAINE | Y8335394RO | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| N204803-001 | POSIMIR | BUPIVACAINE | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | |
| N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD, RS | 2021-02-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD, RS | 2021-02-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD, RS | 2021-02-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD | 2021-02-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD | 2021-02-01 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD | 2021-02-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD | 2021-02-01 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD | 2021-02-01 | 87673890dc5c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION, EXTENDED RELEASE / INFILTRATION | RLD, RS | 2021-02-01 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204803-001 | POSIMIR | 660MG/5ML (132MG/ML) | SOLUTION / INFILTRATION | RLD | 2021-02-01 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204803-001 | 8153149 | 2025-09-15 | Drug product | 2021-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204803-001 | 8153661 | 2025-09-15 | U-3074 | 2021-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204803-001 | 8753665 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204803-001 | 8846072 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204803-001 | 8153149 | 2025-09-15 | Drug product | 2021-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204803-001 | 8153661 | 2025-09-15 | U-3074 | 2021-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204803-001 | 8753665 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204803-001 | 8846072 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204803-001 | 8153149 | 2025-09-15 | Drug product | 2021-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204803-001 | 8153661 | 2025-09-15 | U-3074 | 2021-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204803-001 | 8753665 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204803-001 | 8846072 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204803-001 | 8153149 | 2025-09-15 | Drug product | 2021-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204803-001 | 8153661 | 2025-09-15 | U-3074 | 2021-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204803-001 | 8753665 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204803-001 | 8846072 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204803-001 | 8153149 | 2025-09-15 | Drug product | 2021-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204803-001 | 8153661 | 2025-09-15 | U-3074 | 2021-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204803-001 | 8753665 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204803-001 | 8846072 | 2025-09-15 | U-3074 | Drug product | 2021-03-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204803-001 | 11400019 | 2041-01-12 | Drug product | 2022-09-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204803-001 | 11771624 | 2041-01-12 | U-3724 | 2023-11-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204803-001 | 8153149 | 2025-09-15 | Drug product | 2021-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204803-001 | 8153661 | 2025-09-15 | U-3074 | 2021-03-02 | 2680178bc6a6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204803-001 | NP | 2024-02-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204803-001 | NP | 2024-02-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204803-001 | NP | 2024-02-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204803-001 | NP | 2024-02-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N204803-001 | NP | 2024-02-01 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204803-001 | NP | 2024-02-01 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204803-001 | NP | 2024-02-01 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204803-001 | NP | 2024-02-01 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N204803-001 | NP | 2024-02-01 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204803-001 | NP | 2024-02-01 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N204803-001 | NP | 2024-02-01 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N204803-001 | NP | 2024-02-01 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N204803-001 | NP | 2024-02-01 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N204803-001 | NP | 2024-02-01 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204803-001 | NP | 2024-02-01 | 87673890dc5c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N204803-001 | NP | 2024-02-01 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N204803-001 | NP | 2024-02-01 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N204803-001 | NP | 2024-02-01 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204803-001 | NP | 2024-02-01 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204803-001 | NP | 2024-02-01 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204803-001 | NP | 2024-02-01 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N204803-001 | NP | 2024-02-01 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N204803-001 | NP | 2024-02-01 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N204803-001 | NP | 2024-02-01 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204803-001 | NP | 2024-02-01 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N204803-001 | NP | 2024-02-01 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N204803-001 | NP | 2024-02-01 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N204803-001 | NP | 2024-02-01 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| 2474c73d-640a-16a7-e063-6394a90af357 | efb90d91-f984-294d-e053-2a95a90ad3c4 | 2024-10-14 | Boxed warning | efb90d91-f984-294d-e053-2a95a90ad3c4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.