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 01:33:40
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-112-30 | GM - Gram | 21695-112 | 3c359deb-e9c0-4520-9eeb-299df3c9bded | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21695-112 | 21695-112-30 |
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 |
|---|---|---|---|---|---|---|---|
| N021015-001 | ANDROGEL | TESTOSTERONE | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 |
| N021015-002 | ANDROGEL | TESTOSTERONE | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 |
| N021015-003 | ANDROGEL | TESTOSTERONE | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021015-001 | AB1 |
| N021015-002 | AB1 |
| N021015-003 | AB1 |
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 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | RLD | 2003-09-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | RLD | 2003-09-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | RLD | 2003-09-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 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 | N021015-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021015-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021015-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021015-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021015-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021015-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-003 | AB1 | 1 | d8e5a09893c0… |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | AB | 1 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N021015-001 | AB1 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021015-002 | AB1 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-001 | AB1 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-002 | AB1 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021015-001 | AB1 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021015-002 | AB1 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021015-001 | AB1 | 1 | 8869cabd3fbd… |
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 | N021015-001 | 6503894 | 2020-08-30 | U-490 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 9125816 | 2020-08-30 | U-490 | 2015-09-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 9132089 | 2020-08-30 | U-490 | 2015-09-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 6503894*PED | 2021-03-01 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 9125816*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 9132089*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 6503894 | 2020-08-30 | U-490 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 9125816 | 2020-08-30 | U-490 | 2015-09-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 9132089 | 2020-08-30 | U-490 | 2015-09-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 6503894*PED | 2021-03-01 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 9125816*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 9132089*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 6503894 | 2020-08-30 | U-490 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 9125816 | 2020-08-30 | U-490 | 2015-09-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 9132089 | 2020-08-30 | U-490 | 2015-09-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 6503894*PED | 2021-03-01 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 9125816*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 9132089*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-001 | 6503894*PED | 2021-03-01 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-001 | 9125816*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-001 | 9132089*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-002 | 6503894*PED | 2021-03-01 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-002 | 9125816*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-002 | 9132089*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-003 | 6503894*PED | 2021-03-01 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-003 | 9125816*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-003 | 9132089*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-001 | 6503894*PED | 2021-03-01 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-001 | 9125816*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-001 | 9132089*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-002 | 6503894*PED | 2021-03-01 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-002 | 9125816*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-002 | 9132089*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-003 | 6503894*PED | 2021-03-01 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-003 | 9125816*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-003 | 9132089*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021015-001 | 6503894*PED | 2021-03-01 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021015-001 | 9125816*PED | 2021-03-02 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021015-001 | 9132089*PED | 2021-03-02 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021015-002 | 6503894*PED | 2021-03-01 | Pediatric extension | 5aa47cf7b7d7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.