LISINOPRIL and HYDROCHLOROTHIAZIDE
- Product NDC
- 51407-565
- 11-digit product format
- 514070565
- Labeler code
- 51407
- Product ID
- 51407-565_fd91c3d4-99e0-4b5d-8f6c-d08f19b64703
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LISINOPRIL and HYDROCHLOROTHIAZIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- GSMS, Incorporated
- Application
- ANDA076674
- Marketing category
- ANDA
- Marketing start
- 2025-02-15
- Substance
- HYDROCHLOROTHIAZIDE; LISINOPRIL
- Active strength
- 12.5; 20 mg/1; mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- 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 |
|---|---|---|---|---|---|---|---|
| A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | |
| A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | |
| A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076674-001 | AB |
| A076674-002 | AB |
| A076674-003 | AB |
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 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2004-10-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2004-10-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2004-10-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2004-10-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2004-10-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2004-10-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2004-10-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2004-10-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2004-10-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2004-10-05 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2004-10-05 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2004-10-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2004-10-05 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076674-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2004-10-05 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076674-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2004-10-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076674-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2004-10-05 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076674-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076674-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076674-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076674-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076674-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076674-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076674-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076674-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076674-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076674-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076674-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076674-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076674-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076674-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076674-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076674-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076674-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076674-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076674-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076674-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076674-003 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076674-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076674-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076674-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076674-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076674-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076674-003 | AB | 1 | d06236e962d9… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A076674-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A076674-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A076674-003 | AB | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LISINOPRIL and HYDROCHLOROTHIAZIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LISINOPRIL | 12.5 mg/1 |
| HYDROCHLOROTHIAZIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0J48LPH2TH | Internal UNII lookup |
| E7199S1YWR | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51407-565-05 | LISINOPRIL and HYDROCHLOROTHIAZIDE | 500 in 1 BOTTLE | TABLET | 500 | 1 | |
| 51407-565-90 | LISINOPRIL and HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51407-565-05 | EA - Each | 51407-565 | d0c014ae-b80b-41e5-b2eb-c12ab8b861a0 | 1 | 2025-05-14 |
| 51407-565-90 | EA - Each | 51407-565 | 932e1e60-d477-49f4-b7f4-5b8175b7a2f0 | 1 | 2025-05-14 |
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 |
|---|---|---|---|---|---|---|
| LISINOPRIL and HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | GSMS, Incorporated | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 2025-02-15 | Boxed warning, Warnings, Adverse reactions | 076674 ANDA076674 51407-565 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197885 | lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
| 197887 | lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
| 197885 | hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral Tablet | SCD | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
| 197887 | hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet | SCD | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
| 197885 | HCTZ 12.5 MG / lisinopril 10 MG Oral Tablet | SY | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
| 197887 | HCTZ 25 MG / lisinopril 20 MG Oral Tablet | SY | d02a0d38-676a-4e0f-9aa2-0a6c56cd7361 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51407-565-05 | 51407056505 | 500 TABLET in 1 BOTTLE (51407-565-05) | 500 tablet | 2025-02-15 | No | No | Current |
| 51407-565-90 | 51407056590 | 90 TABLET in 1 BOTTLE (51407-565-90) | 90 tablet | 2025-02-15 | No | No | Current |