HydrALAZINE Hydrochloride
- Product NDC
- 59556-007
- 11-digit product format
- 595560007
- Labeler code
- 59556
- Product ID
- 59556-007_82d20232-4f22-4220-88da-8f8445d79e30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HydrALAZINE Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Inc
- Application
- ANDA200770
- Marketing category
- ANDA
- Marketing start
- 2013-05-04
- Marketing end
- 0000-00-00
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 59556-007 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 59556-007 | 59556-007-06 | D | Discontinued by firm | 2026-09-14 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 59556-007-06 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 59556-007-06 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 59556-007-06 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 59556-007-06 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 59556-007-06 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 59556-007-06 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 59556-007-06 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 59556-007-06 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 59556-007-06 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 59556-007-06 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 59556-007-06 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 59556-007-06 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 59556-007-06 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 59556-007-06 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 59556-007-06 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 59556-007-06 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 59556-007-06 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 59556-007-06 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | I | Inactivated by FDA | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 59556-007-06 | I | Inactivated by FDA | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200770-001 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | |
| A200770-002 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | |
| A200770-003 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | |
| A200770-004 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200770-001 | AA |
| A200770-002 | AA |
| A200770-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200770-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2013-05-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200770-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2013-05-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200770-003 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2013-05-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200770-004 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2019-06-25 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200770-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200770-002 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200770-003 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A200770-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200770-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200770-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200770-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200770-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200770-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200770-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200770-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200770-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200770-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200770-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200770-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200770-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200770-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200770-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200770-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200770-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200770-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200770-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200770-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200770-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200770-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200770-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200770-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200770-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200770-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200770-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200770-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200770-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200770-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200770-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200770-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200770-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200770-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200770-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200770-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200770-001 | AA | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59556-007-06 | 2023-05-03 | C162847 | 48780-1 | 9855d018-d28f-cd31-e053-dbdaa90ab51a | HydrALAZINE Hydrochloride Tablets, USP |
| 59556-007-06 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d28f-cd31-e053-dbdaa90ab51a | HydrALAZINE Hydrochloride Tablets, USP |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | FD171B778Y | HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC] | 1 | |
| HYDRALAZINE | ACTIVE MOIETY | 26NAK24LS8 | HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA INC] | 1 |
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 | Coupler LLC | 58773e8c-b6bc-6bc6-e063-6294a90adc26 | 2026-08-07 | Warnings, Adverse reactions | 200770 ANDA200770 |
| HydrALAZINE Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Strides Pharma Science Limited | b3d1786d-c3ff-42f1-a09f-37a9c9021e5a | 2026-02-02 | Warnings, Adverse reactions | 200770 ANDA200770 |
| HydrALAZINE Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | dfd60a79-2a30-41e6-b000-a144730099a8 | 2019-10-01 | Warnings, Adverse reactions | 200770 ANDA200770 |