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 01:13:22
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50242-063-01 | EA - Each | 50242-063 | 163253e7-57af-4342-b677-7eab5bbe644a | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50242-063 | 50242-063-01 |
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 |
|---|---|---|---|---|---|---|---|
| N021743-001 | TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | |
| N021743-002 | TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | |
| N021743-003 | TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 |
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| 2026-09 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021743-001 | TARCEVA | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021743-002 | TARCEVA | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021743-003 | TARCEVA | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-11-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021743-001 | TARCEVA | EQ 25MG BASE | TABLET / ORAL | RLD | 2004-11-18 | 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 | N021743-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021743-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021743-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021743-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021743-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021743-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021743-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021743-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021743-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021743-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021743-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021743-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021743-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021743-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021743-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021743-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021743-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021743-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021743-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021743-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021743-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021743-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021743-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021743-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021743-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021743-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021743-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-003 | AB | 1 | ea99ee380514… |
| 2023-05-13 08:27 UTC | 2023-05 | N021743-001 | AB | 1 | 053a50430f4f… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 5747498*PED | 2019-05-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | RE41065*PED | 2019-05-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 6900221 | 2020-11-09 | U-875 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 6900221 | 2020-11-09 | U-1403 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 6900221 | 2020-11-09 | U-659 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 6900221 | 2020-11-09 | U-1046 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 7087613 | 2020-11-09 | U-1045 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 7087613 | 2020-11-09 | U-659 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 7087613 | 2020-11-09 | U-1403 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 6900221*PED | 2021-05-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | 7087613*PED | 2021-05-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 5747498*PED | 2019-05-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | RE41065*PED | 2019-05-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 6900221 | 2020-11-09 | U-659 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 6900221 | 2020-11-09 | U-1046 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 6900221 | 2020-11-09 | U-1403 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 6900221 | 2020-11-09 | U-875 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 7087613 | 2020-11-09 | U-659 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 7087613 | 2020-11-09 | U-1403 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 7087613 | 2020-11-09 | U-1045 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 6900221*PED | 2021-05-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | 7087613*PED | 2021-05-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 5747498*PED | 2019-05-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | RE41065*PED | 2019-05-08 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 6900221 | 2020-11-09 | U-875 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 6900221 | 2020-11-09 | U-1403 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 6900221 | 2020-11-09 | U-1046 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 6900221 | 2020-11-09 | U-659 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 7087613 | 2020-11-09 | U-1403 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 7087613 | 2020-11-09 | U-1045 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 7087613 | 2020-11-09 | U-659 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 6900221*PED | 2021-05-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | 7087613*PED | 2021-05-09 | Pediatric extension | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021743-001 | 6900221*PED | 2021-05-09 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021743-001 | 7087613*PED | 2021-05-09 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021743-002 | 6900221*PED | 2021-05-09 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021743-002 | 7087613*PED | 2021-05-09 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021743-003 | 6900221*PED | 2021-05-09 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021743-003 | 7087613*PED | 2021-05-09 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021743-001 | 6900221*PED | 2021-05-09 | Pediatric extension | 87673890dc5c… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | D-164 | 2019-05-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | M-181 | 2019-06-01 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-001 | M-190 | 2019-10-18 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | D-164 | 2019-05-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | M-181 | 2019-06-01 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-002 | M-190 | 2019-10-18 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | D-164 | 2019-05-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | M-181 | 2019-06-01 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021743-003 | M-190 | 2019-10-18 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-001 | D-164 | 2019-05-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-001 | M-181 | 2019-06-01 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-001 | M-190 | 2019-10-18 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-002 | D-164 | 2019-05-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-002 | M-181 | 2019-06-01 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-002 | M-190 | 2019-10-18 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-003 | D-164 | 2019-05-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-003 | M-181 | 2019-06-01 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021743-003 | M-190 | 2019-10-18 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-001 | D-164 | 2019-05-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-001 | M-181 | 2019-06-01 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-001 | M-190 | 2019-10-18 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-002 | D-164 | 2019-05-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-002 | M-181 | 2019-06-01 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-002 | M-190 | 2019-10-18 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-003 | D-164 | 2019-05-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-003 | M-181 | 2019-06-01 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021743-003 | M-190 | 2019-10-18 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-001 | D-164 | 2019-05-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-001 | M-181 | 2019-06-01 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-001 | M-190 | 2019-10-18 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-002 | D-164 | 2019-05-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-002 | M-181 | 2019-06-01 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-002 | M-190 | 2019-10-18 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-003 | D-164 | 2019-05-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-003 | M-181 | 2019-06-01 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021743-003 | M-190 | 2019-10-18 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.