Sildenafil
- Product NDC
- 43353-345
- Requested package NDC
- 43353-345-53
- 11-digit product format
- 433530345
- Labeler code
- 43353
- Product ID
- 43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sildenafil citrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021845
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-09-27
- Substance
- SILDENAFIL CITRATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 43353-345 | 43353-345-53 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021845-001 | REVATIO | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021845-001 | AB |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N021845-001 | M-287 | 2026-01-31 |
| N021845-001 | ODE-469 | 2030-01-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021845-001 | REVATIO | EQ 20MG BASE | TABLET / ORAL | AB | RLD, RS | 2005-06-03 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021845-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021845-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021845-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021845-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021845-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021845-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021845-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021845-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021845-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021845-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021845-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021845-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021845-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021845-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021845-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021845-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021845-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021845-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021845-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021845-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021845-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021845-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021845-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021845-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021845-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021845-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021845-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021845-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021845-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021845-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021845-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021845-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021845-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021845-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021845-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021845-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021845-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021845-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021845-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021845-001 | AB | 1 | e64feba35796… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021845-001 | M-287 | 2026-01-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021845-001 | ODE-469 | 2030-01-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021845-001 | M-287 | 2026-01-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021845-001 | ODE-469 | 2030-01-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021845-001 | M-287 | 2026-01-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021845-001 | ODE-469 | 2030-01-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021845-001 | M-287 | 2026-01-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021845-001 | ODE-469 | 2030-01-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021845-001 | M-287 | 2026-01-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021845-001 | ODE-469 | 2030-01-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021845-001 | M-287 | 2026-01-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021845-001 | ODE-469 | 2030-01-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021845-001 | M-287 | 2026-01-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021845-001 | ODE-469 | 2030-01-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021845-001 | M-287 | 2026-01-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021845-001 | ODE-469 | 2030-01-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021845-001 | M-287 | 2026-01-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021845-001 | ODE-469 | 2030-01-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021845-001 | M-287 | 2026-01-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021845-001 | ODE-469 | 2030-01-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021845-001 | M-287 | 2026-01-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021845-001 | ODE-469 | 2030-01-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021845-001 | M-287 | 2026-01-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021845-001 | ODE-469 | 2030-01-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021845-001 | M-287 | 2026-01-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021845-001 | ODE-469 | 2030-01-31 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021845-001 | M-287 | 2026-01-31 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021845-001 | ODE-469 | 2030-01-31 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021845-001 | M-287 | 2026-01-31 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021845-001 | ODE-469 | 2030-01-31 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021845-001 | M-287 | 2026-01-31 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021845-001 | M-287 | 2026-01-31 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021845-001 | M-287 | 2026-01-31 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021845-001 | M-287 | 2026-01-31 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021845-001 | M-287 | 2026-01-31 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021845-001 | M-287 | 2026-01-31 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021845-001 | M-287 | 2026-01-31 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021845-001 | M-287 | 2026-01-31 | 053a50430f4f… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021845-001 | M-287 | 2026-01-31 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021845-001 | ODE-469 | 2030-01-31 | a50c72e98297… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fabccea2-36c8-9268-ee44-ec231455538f | Product name | 9 | 20241217 |
| ac996ae9-22a2-41c2-bb86-913c4aef95ad | Product name | 1 | 20230606 |
| fc95c9f0-00dc-40ef-bcea-b60c9009c5fc | Product name | 9 | 20220613 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43353-345-10 | Sildenafil | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 1 | |
| 43353-345-20 | Sildenafil | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 1 | |
| 43353-345-53 | Sildenafil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-345-10 | EA - Each | 43353-345 | 876cfb4f-a8e8-4205-9e35-376ca2a7021f | 1 | 2017-12-14 |
| 43353-345-20 | EA - Each | 43353-345 | 2df97703-4ba1-42aa-86e1-1d7d3c8fd169 | 1 | 2017-12-14 |
| 43353-345-53 | EA - Each | 43353-345 | 2a9f5a88-ba8e-436a-b28a-a2c9a42083ba | 1 | 2017-12-14 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Revatio | SILDENAFIL CITRATE | Viatris Specialty LLC | 3bb9363e-b28d-4019-8aae-539233dca214 | 2024-12-18 | Warnings, Adverse reactions | 021845 NDA021845 |
| Revatio | SILDENAFIL CITRATE | PFIZER LABORATORIES DIV PFIZER INC | f158fe10-d5dc-4432-b2c9-fc665401291b | 2023-01-27 | Warnings, Adverse reactions | 021845 NDA021845 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 577033 | sildenafil citrate 20 MG Oral Tablet | PSN | 761f9606-2583-439a-a29e-736008340a9e | 1 |
| 577033 | sildenafil 20 MG Oral Tablet | SCD | 761f9606-2583-439a-a29e-736008340a9e | 1 |
| 577033 | sildenafil 20 MG (as sildenafil citrate) Oral Tablet | SY | 761f9606-2583-439a-a29e-736008340a9e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43353-345-53 | 43353034553 | 60 TABLET, FILM COATED in 1 BOTTLE (43353-345-53) | 2017-07-03 | 0000-00-00 | No | No | Current |