Hydralazine Hydrochloride
- Product NDC
- 51079-075
- 11-digit product format
- 510790075
- Labeler code
- 51079
- Product ID
- 51079-075_3a8625af-ede6-2b68-e063-6394a90a4536
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA088467
- Marketing category
- ANDA
- Marketing start
- 2007-12-26
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088467-001 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A088467-001 | 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 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 1984-05-01 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 1984-05-01 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 1984-05-01 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 1984-05-01 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 1984-05-01 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 1984-05-01 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 1984-05-01 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 1984-05-01 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A088467-001 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RLD, RS | 1984-05-01 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A088467-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088467-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088467-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088467-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088467-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088467-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088467-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088467-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088467-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088467-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088467-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088467-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088467-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088467-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088467-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088467-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088467-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088467-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088467-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088467-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088467-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088467-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088467-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088467-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088467-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088467-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088467-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088467-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088467-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088467-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088467-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088467-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088467-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088467-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088467-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088467-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088467-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A088467-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A088467-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A088467-001 | AA | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydralazine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDRALAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| FD171B778Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 493a8b7e-5bb1-4db2-91a7-77ed87864131 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51079-075-01 | Hydralazine Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | 15 | |
| 51079-075-20 | Hydralazine Hydrochloride | 100 in 1 CARTON | TABLET | 100 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51079-075-01 | EA - Each | 51079-075 | eed4d610-80dd-46a8-87e3-ff698e1d0412 | 1 | 2012-07-24 |
| 51079-075-17 | EA - Each | 51079-075 | 387ffc65-b0ac-46a2-af1c-bc52a7f97ee1 | 1 | 2012-07-24 |
| 51079-075-19 | EA - Each | 51079-075 | 2c4e3e3e-f8e9-425a-840d-3a050dd72918 | 1 | 2012-07-24 |
| 51079-075-20 | EA - Each | 51079-075 | 1850c627-1fdf-41fd-a19a-705f5e6a1cfa | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Safecor Health, LLC | 66c5eaa4-a51a-464b-98ad-f094f32876dd | 2026-03-11 | Warnings, Adverse reactions | 088467 ANDA088467 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | db7500f3-f8a6-46b1-bb64-9727617a9643 | 2025-10-13 | Warnings, Adverse reactions | 088467 ANDA088467 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Mylan Institutional Inc. | 493a8b7e-5bb1-4db2-91a7-77ed87864131 | 2025-07-22 | Warnings, Adverse reactions | 088467 ANDA088467 51079-075 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 7ae650f7-a481-4637-a9a2-9bda43a5a288 | 2024-12-24 | Warnings, Adverse reactions | 088467 ANDA088467 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 10f3e76e-9bba-4151-89fb-90d823a0a68c | 2024-11-08 | Warnings, Adverse reactions | 088467 ANDA088467 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | bfbd5960-ae6b-46f5-adfa-e330d7a21dfa | 2017-12-21 | Warnings, Adverse reactions | 088467 ANDA088467 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | ddbbdb09-3202-42d7-bbb0-08331dde2f54 | 2016-02-29 | Warnings, Adverse reactions | 088467 ANDA088467 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 905225 | hydrALAZINE HCl 25 MG Oral Tablet | PSN | db7500f3-f8a6-46b1-bb64-9727617a9643 | 18 |
| 905395 | hydrALAZINE HCl 50 MG Oral Tablet | PSN | db7500f3-f8a6-46b1-bb64-9727617a9643 | 18 |
| 905225 | hydralazine hydrochloride 25 MG Oral Tablet | SCD | db7500f3-f8a6-46b1-bb64-9727617a9643 | 18 |
| 905395 | hydralazine hydrochloride 50 MG Oral Tablet | SCD | db7500f3-f8a6-46b1-bb64-9727617a9643 | 18 |
| 905199 | hydrALAZINE HCl 10 MG Oral Tablet | PSN | 493a8b7e-5bb1-4db2-91a7-77ed87864131 | 15 |
| 905225 | hydrALAZINE HCl 25 MG Oral Tablet | PSN | 493a8b7e-5bb1-4db2-91a7-77ed87864131 | 15 |
| 905395 | hydrALAZINE HCl 50 MG Oral Tablet | PSN | 493a8b7e-5bb1-4db2-91a7-77ed87864131 | 15 |
| 905199 | hydralazine hydrochloride 10 MG Oral Tablet | SCD | 493a8b7e-5bb1-4db2-91a7-77ed87864131 | 15 |
| 905225 | hydralazine hydrochloride 25 MG Oral Tablet | SCD | 493a8b7e-5bb1-4db2-91a7-77ed87864131 | 15 |
| 905395 | hydralazine hydrochloride 50 MG Oral Tablet | SCD | 493a8b7e-5bb1-4db2-91a7-77ed87864131 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51079-075-01 | 51079007501 | 1 in 1 BLISTER PACK | Historical | |||||
| 51079-075-20 | 51079007520 | 100 BLISTER PACK in 1 CARTON (51079-075-20) / 1 TABLET in 1 BLISTER PACK (51079-075-01) | 100 blister pack | 2007-12-26 | 0000-00-00 | No | No | Current |