SILDENAFIL
- Product NDC
- 69097-952
- 11-digit product format
- 690970952
- Labeler code
- 69097
- Product ID
- 69097-952_31499b53-d7e9-49e4-8eaa-c527c7403f9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SILDENAFIL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- CIPLA USA INC.,
- Application
- ANDA207178
- Marketing category
- ANDA
- Marketing start
- 2020-07-10
- Substance
- SILDENAFIL CITRATE
- Active strength
- 50 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 69097-952-02 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 69097-952-07 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 69097-952-02 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 69097-952-07 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 69097-952-02 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 69097-952-07 | bd6a592717d7… | 303034d00443… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207178-001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | |
| A207178-002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | |
| A207178-003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207178-001 | AB |
| A207178-002 | AB |
| A207178-003 | AB |
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 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207178-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2020-03-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207178-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2020-03-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207178-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2020-03-02 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207178-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207178-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207178-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207178-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207178-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207178-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207178-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207178-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207178-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207178-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207178-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207178-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207178-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207178-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207178-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207178-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207178-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207178-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207178-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207178-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207178-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207178-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207178-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207178-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207178-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207178-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207178-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207178-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207178-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207178-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207178-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207178-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207178-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207178-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207178-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207178-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207178-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207178-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207178-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207178-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SILDENAFIL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SILDENAFIL CITRATE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BW9B0ZE037 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15372a7c-2935-48dc-a55a-8966719b50be | Available on FDA.report |
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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69097-952-02 | SILDENAFIL | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 69097-952-07 | SILDENAFIL | 100 in 1 BOTTLE | TABLET | 100 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69097-952-02 | EA - Each | 69097-952 | 4746e815-4f79-46ec-938e-f2113585f62d | 1 | 2020-08-06 |
| 69097-952-07 | EA - Each | 69097-952 | d5c021ca-e367-4665-82b3-7ed39ad56371 | 1 | 2020-08-06 |
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 |
|---|---|---|---|---|---|---|
| SILDENAFIL | SILDENAFIL | Appco Pharma LLC | df1cc749-caec-4bf0-aa4d-db9dcc5257c3 | 2026-02-11 | Warnings, Adverse reactions | 207178 ANDA207178 |
| SILDENAFIL | SILDENAFIL | Aphena Pharma Solutions - Tennessee, LLC | cdab7ef5-39cb-45cc-b2bf-5f634f2f5499 | 2023-11-09 | Warnings, Adverse reactions | 207178 ANDA207178 |
| SILDENAFIL | SILDENAFIL | CIPLA USA INC., | 15372a7c-2935-48dc-a55a-8966719b50be | 2023-05-02 | Warnings, Adverse reactions | 207178 ANDA207178 69097-952 |
| SILDENAFIL | SILDENAFIL | Exelan Pharmaceuticals, Inc. | 1883785c-a1a4-48fe-b722-afacf2875ca8 | 2022-08-03 | Warnings, Adverse reactions | 207178 ANDA207178 |
| SILDENAFIL | SILDENAFIL | Proficient Rx LP | 7086e222-0f2b-4c02-84c0-4f8635c90993 | 2021-03-01 | Warnings, Adverse reactions | 207178 ANDA207178 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314229 | sildenafil citrate 100 MG Oral Tablet | PSN | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
| 314228 | sildenafil citrate 25 MG Oral Tablet | PSN | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
| 312950 | sildenafil citrate 50 MG Oral Tablet | PSN | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
| 314229 | sildenafil 100 MG Oral Tablet | SCD | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
| 314228 | sildenafil 25 MG Oral Tablet | SCD | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
| 312950 | sildenafil 50 MG Oral Tablet | SCD | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
| 314229 | sildenafil 100 MG (as sildenafil citrate) Oral Tablet | SY | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
| 314228 | sildenafil 25 MG (as sildenafil citrate) Oral Tablet | SY | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
| 312950 | sildenafil 50 MG (as sildenafil citrate) Oral Tablet | SY | 15372a7c-2935-48dc-a55a-8966719b50be | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69097-952-02 | 69097095202 | 30 TABLET in 1 BOTTLE (69097-952-02) | 30 tablet | 2020-07-10 | 0000-00-00 | No | No | Current |
| 69097-952-07 | 69097095207 | 100 TABLET in 1 BOTTLE (69097-952-07) | 100 tablet | 2020-07-10 | 0000-00-00 | No | No | Current |