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 02:50:54
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0051-8462-33 | GM - Gram | 0051-8462 | d64c8784-bd5d-4d35-8e79-99bab638f335 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0051-8462 | 0051-8462-33 |
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 |
|---|---|---|---|---|---|---|---|
| N022309-001 | ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 |
| N022309-002 | ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 |
| N022309-003 | ANDROGEL | TESTOSTERONE | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022309-001 | AB |
| N022309-002 | AB2 |
| N022309-003 | AB2 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022309-001 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | |
| N022309-001 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-001 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-001 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | |
| N022309-001 | 8729057 | 2026-10-12 | Drug product | ||
| N022309-001 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | |
| N022309-001 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | |
| N022309-001 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | |
| N022309-002 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | |
| N022309-002 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-002 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-002 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | |
| N022309-002 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | |
| N022309-002 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | |
| N022309-002 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | |
| N022309-002 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | |
| N022309-003 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | |
| N022309-003 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-003 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-003 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | |
| N022309-003 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | |
| N022309-003 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | |
| N022309-003 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | |
| N022309-003 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 |
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 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022309-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | AB2 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022309-003 | AB2 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-003 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-002 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-003 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-003 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022309-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-003 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022309-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022309-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022309-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022309-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022309-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022309-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022309-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022309-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022309-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022309-002 | AB2 | 1 | 74a2ff9319b5… |
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 | N022309-001 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-001 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-001 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-001 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-001 | 8729057 | 2026-10-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022309-001 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-001 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-001 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-002 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022309-003 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | 8729057 | 2026-10-12 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-001 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022309-002 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | caaa826d4ba7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.