SPIRONOLACTONE
- Product NDC
- 17856-1233
- 11-digit product format
- 178561233
- Labeler code
- 17856
- Product ID
- 17856-1233_5a203aec-a8c0-ffc7-e063-6394a90aba88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corp.
- Application
- NDA209478
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-10-31
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/5mL
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209478-001 | CAROSPIR | SPIRONOLACTONE | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N209478-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209478-001 | 10493083 | 2036-10-28 | Drug product | 2020-01-02 | |
| N209478-001 | 10624906 | 2036-10-28 | Drug product | 2020-04-27 | |
| N209478-001 | 10660907 | 2036-10-28 | Drug product | 2020-06-15 | |
| N209478-001 | 10888570 | 2036-10-28 | Drug product | 2021-01-15 | |
| N209478-001 | 11389461 | 2036-10-28 | Drug product | 2022-07-22 | |
| N209478-001 | 11395828 | 2036-10-28 | U-2109 | 2022-08-02 | |
| N209478-001 | 11395828 | 2036-10-28 | U-3401 | 2022-08-02 | |
| N209478-001 | 11395828 | 2036-10-28 | U-3402 | 2022-08-02 | |
| N209478-001 | 11491166 | 2036-10-28 | Drug product | 2022-11-18 | |
| N209478-001 | 9757394 | 2036-10-28 | U-2109 | Drug product | 2017-09-21 |
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 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2017-08-04 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N209478-001 | CAROSPIR | 25MG/5ML | SUSPENSION / ORAL | RLD, RS | 2017-08-04 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209478-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209478-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209478-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209478-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209478-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209478-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209478-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209478-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209478-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209478-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209478-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209478-001 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209478-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N209478-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N209478-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209478-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209478-001 | AB | 1 | 9b2671bbb829… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209478-001 | AB | 1 | a50c72e98297… |
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 | N209478-001 | 10493083 | 2036-10-28 | Drug product | 2020-01-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 10624906 | 2036-10-28 | Drug product | 2020-04-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 10660907 | 2036-10-28 | Drug product | 2020-06-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 10888570 | 2036-10-28 | Drug product | 2021-01-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 11389461 | 2036-10-28 | Drug product | 2022-07-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 11395828 | 2036-10-28 | U-2109 | 2022-08-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 11395828 | 2036-10-28 | U-3401 | 2022-08-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 11395828 | 2036-10-28 | U-3402 | 2022-08-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 11491166 | 2036-10-28 | Drug product | 2022-11-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209478-001 | 9757394 | 2036-10-28 | U-2109 | Drug product | 2017-09-21 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 10493083 | 2036-10-28 | Drug product | 2020-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 10624906 | 2036-10-28 | Drug product | 2020-04-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 10660907 | 2036-10-28 | Drug product | 2020-06-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 10888570 | 2036-10-28 | Drug product | 2021-01-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 11389461 | 2036-10-28 | Drug product | 2022-07-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 11395828 | 2036-10-28 | U-2109 | 2022-08-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 11395828 | 2036-10-28 | U-3401 | 2022-08-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 11395828 | 2036-10-28 | U-3402 | 2022-08-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 11491166 | 2036-10-28 | Drug product | 2022-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209478-001 | 9757394 | 2036-10-28 | U-2109 | Drug product | 2017-09-21 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 10493083 | 2036-10-28 | Drug product | 2020-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 10624906 | 2036-10-28 | Drug product | 2020-04-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 10660907 | 2036-10-28 | Drug product | 2020-06-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 10888570 | 2036-10-28 | Drug product | 2021-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 11389461 | 2036-10-28 | Drug product | 2022-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 11395828 | 2036-10-28 | U-2109 | 2022-08-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 11395828 | 2036-10-28 | U-3401 | 2022-08-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 11395828 | 2036-10-28 | U-3402 | 2022-08-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 11491166 | 2036-10-28 | Drug product | 2022-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209478-001 | 9757394 | 2036-10-28 | U-2109 | Drug product | 2017-09-21 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 10493083 | 2036-10-28 | Drug product | 2020-01-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 10624906 | 2036-10-28 | Drug product | 2020-04-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 10660907 | 2036-10-28 | Drug product | 2020-06-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 10888570 | 2036-10-28 | Drug product | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 11389461 | 2036-10-28 | Drug product | 2022-07-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 11395828 | 2036-10-28 | U-2109 | 2022-08-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 11395828 | 2036-10-28 | U-3401 | 2022-08-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 11395828 | 2036-10-28 | U-3402 | 2022-08-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 11491166 | 2036-10-28 | Drug product | 2022-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209478-001 | 9757394 | 2036-10-28 | U-2109 | Drug product | 2017-09-21 | 31067a03dcf5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SPIRONOLACTONE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SPIRONOLACTONE | 25 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 27O7W4T232 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 104232 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5a203ae4-0ed1-0099-e063-6294a90abc85 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| SPIRONOLACTONE | SPIRONOLACTONE | Atlantic Biologicals Corp. | 5a203ae4-0ed1-0099-e063-6294a90abc85 | 2026-08-28 | Warnings, Adverse reactions | 209478 NDA209478 17856-1233 |
| SPIRONOLACTONE | SPIRONOLACTONE | ATLANTIC BIOLOGICALS CORP. | 122558a0-57bb-4195-9adf-d37b049cbfb5 | 2026-08-26 | Warnings, Adverse reactions | 209478 NDA209478 |
| SPIRONOLACTONE | SPIRONOLACTONE | Padagis US LLC | 522bd365-ddcc-48f4-8a98-66dc4c3bb314 | 2025-01-01 | Warnings, Adverse reactions | 209478 NDA209478 |
| CaroSpir | CAROSPIR | CMP Pharma, Inc. | c4f70a04-7d89-4b73-8b02-17d43471bf08 | 2023-09-15 | Warnings, Adverse reactions | 209478 NDA209478 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17856-1233-1 | 17856123301 | 110 SYRINGE in 1 CASE (17856-1233-1) / 1 mL in 1 SYRINGE | 110 syringe | 2026-08-28 | No | No | Current |
| 17856-1233-2 | 17856123302 | 45 SYRINGE in 1 CASE (17856-1233-2) / 2.5 mL in 1 SYRINGE | 45 syringe | 2026-08-28 | No | No | Current |
| 17856-1233-3 | 17856123303 | 110 SYRINGE in 1 CASE (17856-1233-3) / 3 mL in 1 SYRINGE | 110 syringe | 2026-08-28 | No | No | Current |