Hydralazine Hydrochloride
- Product NDC
- 55154-6628
- 11-digit product format
- 551546628
- Labeler code
- 55154
- Product ID
- 55154-6628_9b83bc08-9a57-4b18-bb9a-cda537a276e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health
- Application
- ANDA086242
- Marketing category
- ANDA
- Marketing start
- 2010-09-10
- Marketing end
- 0000-00-00
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 10 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 | 55154-6628 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 55154-6628 | 55154-6628-0 | D | Discontinued by firm | 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 55154-6628 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55154-6628 | 55154-6628-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 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 | 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… |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55154-6628 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 12 | Legacy NDC | 20240508_993a4f55-421b-4c41-af0f-7f6237b8e429.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 | PD-Rx Pharmaceuticals, Inc. | 4671cefa-4468-4116-ba40-3d3b0f581ea1 | 2026-06-09 | Warnings, Adverse reactions | 086242 ANDA086242 |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | db138daf-2d2d-4730-a621-a1bd209d5b9f | 2026-04-03 | Warnings, Adverse reactions | 086242 ANDA086242 |
| 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 | Northwind Health Company, LLC | ab1c6f37-3b64-23fb-e053-2995a90a932f | 2026-01-01 | Warnings, Adverse reactions | 086242 ANDA086242 |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Northwind Health Company, LLC | ada28f78-e933-7acf-e053-2995a90ae316 | 2026-01-01 | 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55154-6628-0 | 55154662800 | 10 BLISTER PACK in 1 BAG (55154-6628-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2010-09-10 | 0000-00-00 | No | No | Current |