Hydralazine Hydrochloride
- Product NDC
- 53808-1062
- 11-digit product format
- 538081062
- Labeler code
- 53808
- Product ID
- 53808-1062_69eefde6-630a-4bee-8b98-fadde8ceaa43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA040901
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- Marketing end
- 0000-00-00
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 53808-1062 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 53808-1062 | 53808-1062-1 | I | Inactivated by FDA | 2026-08-10 |
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 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53808-1062-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53808-1062-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53808-1062-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53808-1062-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53808-1062-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53808-1062-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53808-1062-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53808-1062-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53808-1062-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53808-1062-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53808-1062-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53808-1062-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 53808-1062-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 53808-1062-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 53808-1062-1 | 1332a3947898… | d4bfe170f9cd… |
| 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 | 53808-1062-1 | 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 | 53808-1062-1 | 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 | 53808-1062-1 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 53808-1062-1 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53808-1062-1 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 53808-1062-1 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040901-001 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | |
| A040901-002 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | |
| A040901-003 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | |
| A040901-004 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040901-001 | AA |
| A040901-002 | AA |
| A040901-003 | AA |
| A040901-004 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040901-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2008-09-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040901-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2008-09-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040901-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2008-09-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040901-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2008-09-12 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040901-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040901-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040901-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040901-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040901-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040901-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040901-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040901-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040901-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040901-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040901-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040901-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040901-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040901-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040901-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040901-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040901-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040901-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040901-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040901-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040901-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040901-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040901-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040901-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040901-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040901-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040901-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040901-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040901-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040901-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040901-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040901-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040901-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040901-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040901-003 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040901-004 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040901-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040901-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040901-003 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040901-004 | AA | 1 | d06236e962d9… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a3137695-e199-b3b3-2950-87a8ac429689 | Product name | 5 | 20260316 |
| e9ed2ee5-d109-4795-bffe-c3b047717749 | Product name | 2 | 20250107 |
| 0284f4a6-db58-dacf-18fe-da73f4aeea88 | Product name | 4 | 20180827 |
| 0ad8bdca-888e-00da-648b-6a4de854a167 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-1062-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-093c-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-1062-1 | Hydralazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | FD171B778Y | HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYDRALAZINE | ACTIVE MOIETY | 26NAK24LS8 | HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-1062 | HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20150107_2c65df39-26d8-4428-8306-d43cbfcaf162.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 |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 438479d0-ff61-4008-a0fc-1ee44b97cf7f | 2026-05-07 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 89afc8ef-27c4-489a-81de-3f8f65f6bbb8 | 2026-02-09 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | 7253aaa0-e272-499f-9bfa-304e9556a8fb | 2025-12-05 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | f16f1d87-f9e6-4555-9baf-26ff17cb1d28 | 2025-12-05 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | d2d98842-ff32-4a61-94e0-60e06919948f | 2025-09-26 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | a79ddc89-546b-4808-879d-c0f592141636 | 2025-03-31 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 90c18c55-3045-4a10-a2bb-012e4a5e1564 | 2025-03-25 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 5da36930-d3da-4b5c-9e22-2b141bc01a9c | 2025-03-13 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 775e99c4-e18d-4648-a0e3-8709950249ff | 2025-02-01 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a862321d-ebc1-7676-e053-2995a90a5861 | 2024-12-17 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | f07abdec-6d94-45b6-be1b-10a898ea28c2 | 2024-08-12 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3b61d1b0-c699-67a8-e054-00144ff88e88 | 2024-07-16 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4b7d3378-86f8-0a5f-e054-00144ff8d46c | 2024-07-15 | Warnings, Adverse reactions | 040901 ANDA040901 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 48cf71dd-19dc-4239-9117-ebcf9731a45d | 2019-10-01 | Warnings, Adverse reactions | 040901 ANDA040901 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 905395 | hydrALAZINE HCl 50 MG Oral Tablet | PSN | 2c65df39-26d8-4428-8306-d43cbfcaf162 | 1 |
| 905395 | hydralazine hydrochloride 50 MG Oral Tablet | SCD | 2c65df39-26d8-4428-8306-d43cbfcaf162 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-1062-1 | 53808106201 | 30 in 1 BLISTER PACK | Historical |