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 01:55:56
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-0387-25 | ML - Milliliter | 0078-0387 | 64478bff-8e95-4cf2-bcf3-b2e192b39326 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0078-0387 | 0078-0387-25 |
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 |
|---|---|---|---|---|---|---|---|
| N021223-001 | ZOMETA | ZOLEDRONIC ACID | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | |
| N021223-002 | ZOMETA | ZOLEDRONIC ACID | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | |
| N021223-003 | ZOMETA | ZOLEDRONIC ACID | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 |
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 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021223-002 | ZOMETA | EQ 4MG BASE/5ML | INJECTABLE / INTRAVENOUS | RLD | 2003-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021223-003 | ZOMETA | EQ 4MG BASE/100ML | INJECTABLE / INTRAVENOUS | RLD | 2011-06-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021223-001 | ZOMETA | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INTRAVENOUS | RLD | 2001-08-20 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021223-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021223-003 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021223-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021223-003 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021223-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021223-003 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021223-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021223-003 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021223-002 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021223-003 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021223-002 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021223-003 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021223-002 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021223-003 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021223-002 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021223-003 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021223-002 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021223-003 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021223-002 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021223-003 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021223-002 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021223-003 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021223-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021223-003 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021223-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021223-003 | AP | 1 | ea99ee380514… |
| 2023-12-20 04:57 UTC | 2023-12 | N021223-002 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N021223-003 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021223-002 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021223-003 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021223-002 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021223-003 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021223-002 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021223-003 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021223-002 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021223-003 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021223-002 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N021223-003 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021223-002 | AP | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N021223-003 | AP | 1 | 3bdfa0b2c4d7… |
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 | N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-002 | 8324189 | 2025-05-29 | U-1308 | 2012-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-002 | 8324189 | 2025-05-29 | U-1309 | 2012-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-002 | 8324189 | 2025-05-29 | U-53 | 2012-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-002 | 8324189*PED | 2025-11-29 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-003 | 8324189 | 2025-05-29 | U-1308 | 2012-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-003 | 8324189 | 2025-05-29 | U-1309 | 2012-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-003 | 8324189 | 2025-05-29 | U-53 | 2012-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-003 | 8324189*PED | 2025-11-29 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-002 | 8324189 | 2025-05-29 | U-1308 | 2012-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-002 | 8324189 | 2025-05-29 | U-1309 | 2012-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-002 | 8324189 | 2025-05-29 | U-53 | 2012-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-002 | 8324189*PED | 2025-11-29 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021223-003 | 8324189 | 2025-05-29 | U-1308 | 2012-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-003 | 8324189 | 2025-05-29 | U-1309 | 2012-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-003 | 8324189 | 2025-05-29 | U-53 | 2012-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021223-003 | 8324189*PED | 2025-11-29 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-002 | 8324189 | 2025-05-29 | U-1308 | 2012-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-002 | 8324189 | 2025-05-29 | U-1309 | 2012-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-002 | 8324189 | 2025-05-29 | U-53 | 2012-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-002 | 8324189*PED | 2025-11-29 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-003 | 8324189 | 2025-05-29 | U-1308 | 2012-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-003 | 8324189 | 2025-05-29 | U-1309 | 2012-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-003 | 8324189 | 2025-05-29 | U-53 | 2012-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-003 | 8324189*PED | 2025-11-29 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-002 | 8324189 | 2025-05-29 | U-1308 | 2012-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-002 | 8324189 | 2025-05-29 | U-1309 | 2012-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-002 | 8324189 | 2025-05-29 | U-53 | 2012-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-002 | 8324189*PED | 2025-11-29 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-003 | 8324189 | 2025-05-29 | U-1308 | 2012-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-003 | 8324189 | 2025-05-29 | U-1309 | 2012-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-003 | 8324189 | 2025-05-29 | U-53 | 2012-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-003 | 8324189*PED | 2025-11-29 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021223-003 | 7932241 | 2028-02-05 | Drug product | 2011-06-30 | b8a1b40f171c… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.