HYDRALAZINE HYDROCHLORIDE
- Product NDC
- 71335-0482
- 11-digit product format
- 713350482
- Labeler code
- 71335
- Product ID
- 71335-0482_b8a169cd-ad05-4e3d-b926-bd5cd753d540
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydralazine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA086242
- Marketing category
- ANDA
- Marketing start
- 2007-04-06
- 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
- 2023-12-31
- 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 | 71335-0482 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 71335-0482 | 71335-0482-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0482 | 71335-0482-2 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0482 | 71335-0482-3 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0482 | 71335-0482-4 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71335-0482 | 71335-0482-5 | D | Discontinued by firm | 2026-10-05 |
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 | 71335-0482-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0482-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0482-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0482-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0482-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0482-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0482-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0482-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0482-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0482-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0482-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0482-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0482-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0482-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0482-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0482-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0482-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0482-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0482-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0482-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0482-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0482-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71335-0482-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71335-0482-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71335-0482-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71335-0482-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71335-0482-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71335-0482-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71335-0482-5 | 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 | 71335-0482-4 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 71335-0482-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 71335-0482-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 71335-0482-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 71335-0482-5 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A086242-001 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-02-04 | ||
| A086242-002 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | ||
| A086242-003 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | ||
| A086242-004 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2010-02-04 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-02-04 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2010-02-04 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-02-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2010-02-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A086242-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-003 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-004 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-003 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-004 | AA | 1 | d06236e962d9… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 71335-0482-1 | 2024-04-18 | Rx only |
| 71335-0482-2 | 2024-04-18 | Rx only |
| 71335-0482-3 | 2024-04-18 | Rx only |
| 71335-0482-4 | 2024-04-18 | Rx only |
| 71335-0482-5 | 2024-04-18 | Rx only |
| 71335-0482-1 | 2024-01-30 | Rx only |
| 71335-0482-2 | 2024-01-30 | Rx only |
| 71335-0482-3 | 2024-01-30 | Rx only |
| 71335-0482-4 | 2024-01-30 | Rx only |
| 71335-0482-5 | 2024-01-30 | Rx only |
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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | a04eefaf-ba3c-448d-8ece-4aa9ab2e3508 | 2026-01-09 | Warnings, Adverse reactions | 086242 ANDA086242 |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e9450e82-329f-4fd8-a0b3-3e8e22715965 | 2026-01-07 | Warnings, Adverse reactions | 086242 ANDA086242 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Chartwell RX, LLC | 0c7f9bd0-6c0a-4521-b77a-3582faa96874 | 2025-12-10 | Warnings, Adverse reactions | 086242 ANDA086242 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 63f388e0-9f3d-4902-990c-9a105aa098ad | 2020-09-01 | Warnings, Adverse reactions | 086242 ANDA086242 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-0482-1 | 71335048201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0482-1) | 2015-12-15 | 0000-00-00 | No | No | Current |
| 71335-0482-2 | 71335048202 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0482-2) | 2015-12-15 | 0000-00-00 | No | No | Current |
| 71335-0482-3 | 71335048203 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0482-3) | 2015-12-15 | 0000-00-00 | No | No | Current |
| 71335-0482-4 | 71335048204 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0482-4) | 2015-12-15 | 0000-00-00 | No | No | Current |
| 71335-0482-5 | 71335048205 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-0482-5) | 2021-12-27 | 0000-00-00 | No | No | Current |