NDC 63275-9868-8 - Vardenafil HCl Trihydrate
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 63275-9868
- Requested NDC
- 63275-9868-8
- Package NDCs from labels
- 63275-9868-4, 63275-9868-5, 63275-9868-8, 63275-9868-9
- Manufacturer
- B&B Pharmaceuticals, Inc.
- Effective date
- 2020-04-22
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Vardenafil HCl Trihydrate | B&B Pharmaceuticals, Inc. | 2020-04-22 | BULK INGREDIENT |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63275-9868-4 | GM - Gram | 63275-9868 | e4d5c4d1-8e3e-4ea3-8c91-431edeaae5d6 | 1 | 2020-05-08 |
| 63275-9868-5 | GM - Gram | 63275-9868 | 44709f03-34db-4a7b-8525-06c4b450c067 | 1 | 2020-05-08 |
| 63275-9868-8 | GM - Gram | 63275-9868 | b2b7eb5e-34bd-41e2-ac3f-ecd01f3f1e73 | 1 | 2020-05-08 |
| 63275-9868-9 | GM - Gram | 63275-9868 | e7b6a199-429f-40d0-957c-0a2d0a8a14d5 | 1 | 2020-05-08 |
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 |
|---|---|---|---|---|---|---|
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 083a3282-254f-4042-b0eb-70f76a279f10 | 2026-08-27 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 6d2859a7-6def-455f-856b-9db86b1fd355 | 2026-08-27 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 666a622b-2464-4c55-8c90-0f1cc85bc1e9 | 2026-08-26 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 8791997d-3b86-45af-988f-808e259da506 | 2026-08-26 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Lannett Company, Inc. | 2782efed-6198-47b9-81ac-3e255e2ab7f6 | 2026-07-15 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | AvKARE | 80c4793d-e19e-10f0-e053-2991aa0a4620 | 2026-01-15 | Warnings, Adverse reactions | 5M8S2CU0TS |
| VARDENAFIL | VARDENAFIL | Zydus Lifesciences Limited | 8ea14f7e-44a0-4d9c-968a-87b97ca12f09 | 2026-01-05 | 5M8S2CU0TS | |
| VARDENAFIL | VARDENAFIL | Zydus Pharmaceuticals USA Inc. | 5876e062-e604-42a7-99c3-5da30b8dac06 | 2026-01-05 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Chartwell RX, LLC | 57a0c163-a5e8-4c6e-a4ea-114cb2668407 | 2025-12-10 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil | VARDENAFIL | Alembic Pharmaceuticals Inc. | 0ce4eb7b-fa50-441d-ae71-eb33dca27926 | 2025-07-30 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | AvKARE | 3b03952b-d404-09cd-e063-6294a90a8b2c | 2025-07-28 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil | VARDENAFIL | Macleods Pharmaceuticals Limited | 0ad213e0-d18a-4e67-a405-df95322eaa52 | 2025-01-31 | Warnings, Adverse reactions | 5M8S2CU0TS |
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | d8a5cc4b-9d9d-43af-9ee4-57381aa6368a | 2024-05-28 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 31be68b0-ac7e-42d0-9435-1f0a329b63d8 | 2024-04-03 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | e593ab58-70a4-4095-8091-16a4b6d49e4d | 2023-12-08 | Warnings, Adverse reactions | 5M8S2CU0TS |
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | d2dce236-257e-44b6-93a9-9f0280257c6a | 2023-03-22 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil | VARDENAFIL | Alembic Pharmaceuticals Limited | dce0b31b-4522-4cb4-9dba-3aea2b2bb082 | 2023-01-24 | Warnings, Adverse reactions | 5M8S2CU0TS |
| VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 9b8da728-8f52-4c1f-9f0c-4bd9736e912f | 2023-01-24 | Warnings, Adverse reactions | 5M8S2CU0TS |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 09366eb3-93e0-41d9-bf9a-24335ed3555f | 2021-01-27 | Warnings, Adverse reactions | 5M8S2CU0TS |
| VARDENAFIL | VARDENAFIL | Aphena Pharma Solutions - Tennessee, LLC | c70a9c8e-46b0-489d-bbda-2d7fca4b629f | 2020-11-11 | Warnings, Adverse reactions | 5M8S2CU0TS |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.