Sildenafil
- Product NDC
- 63629-7833
- Requested package NDC
- 63629-7833-2
- 11-digit product format
- 636297833
- Labeler code
- 63629
- Product ID
- 63629-7833_d46344f0-a486-4a8b-b941-bf03c75aa7b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202023
- Marketing category
- ANDA
- Marketing start
- 2018-06-28
- 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 63629-7833 | 63629-7833-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 63629-7833 | 63629-7833-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202023-001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | |
| A202023-002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | |
| A202023-003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202023-001 | AB |
| A202023-002 | AB |
| A202023-003 | 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 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202023-002 | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET / ORAL | AB | 2018-06-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202023-003 | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET / ORAL | AB | 2018-06-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202023-001 | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET / ORAL | AB | 2018-06-27 | 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 | A202023-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202023-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202023-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202023-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202023-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202023-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202023-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202023-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202023-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202023-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202023-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202023-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202023-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202023-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202023-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202023-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202023-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202023-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202023-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202023-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202023-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202023-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202023-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202023-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202023-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202023-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202023-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202023-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202023-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202023-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202023-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202023-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202023-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202023-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202023-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202023-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202023-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202023-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202023-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202023-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sildenafil
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SILDENAFIL CITRATE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BW9B0ZE037 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dfe4f616-b5de-458c-a97b-ab860e32320c | 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 |
|---|---|---|---|---|---|---|
| 63629-7833-1 | Sildenafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 63629-7833-2 | Sildenafil | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 9 | |
| 63629-7833-3 | Sildenafil | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 9 | |
| 63629-7833-4 | Sildenafil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 9 | |
| 63629-7833-5 | Sildenafil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 9 | |
| 63629-7833-6 | Sildenafil | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 9 | |
| 63629-7833-7 | Sildenafil | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-7833 | SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK] | 9 | Current NDC, Legacy NDC, 7 package rows | 20240516_dfe4f616-b5de-458c-a97b-ab860e32320c.zip |
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 | Bryant Ranch Prepack | dfe4f616-b5de-458c-a97b-ab860e32320c | 2026-08-11 | Warnings, Adverse reactions | 202023 ANDA202023 63629-7833-2 63629-7833 63629783302 |
| Sildenafil | SILDENAFIL | Amneal Pharmaceuticals NY LLC | a1c3a2a2-8cf5-41c3-9c86-54290570d916 | 2026-07-06 | Warnings, Adverse reactions | 202023 ANDA202023 |
| Sildenafil | SILDENAFIL | NuCare Pharmaceuticals,Inc. | f98d51a5-e3c8-2b6c-e053-6294a90ac146 | 2025-02-10 | Warnings, Adverse reactions | 202023 ANDA202023 |
| Sildenafil | SILDENAFIL | Bryant Ranch Prepack | 96ae6733-cef9-46cf-bf4e-5368201943bd | 2024-05-17 | Warnings, Adverse reactions | 202023 ANDA202023 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312950 | sildenafil citrate 50 MG Oral Tablet | PSN | dfe4f616-b5de-458c-a97b-ab860e32320c | 9 |
| 312950 | sildenafil 50 MG Oral Tablet | SCD | dfe4f616-b5de-458c-a97b-ab860e32320c | 9 |
| 312950 | sildenafil 50 MG (as sildenafil citrate) Oral Tablet | SY | dfe4f616-b5de-458c-a97b-ab860e32320c | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-7833-2 | 63629783302 | 10 TABLET, FILM COATED in 1 BOTTLE (63629-7833-2) | 2019-01-28 | 0000-00-00 | No | No | Current |