Lisinopril and Hydrochlorothiazide
- Product NDC
- 80425-0207
- 11-digit product format
- 804250207
- Labeler code
- 80425
- Product ID
- 80425-0207_2a99e9e8-3d1b-ee0b-e063-6294a90ae4ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisinopril and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA076230
- Marketing category
- ANDA
- Marketing start
- 2022-11-04
- Substance
- HYDROCHLOROTHIAZIDE; LISINOPRIL
- Active strength
- 12.5; 10 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 |
|---|---|---|---|---|---|---|---|
| A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076230-001 | AB |
| A076230-002 | AB |
| A076230-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076230-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076230-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076230-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076230-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076230-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076230-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076230-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076230-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076230-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076230-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076230-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076230-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076230-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076230-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076230-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076230-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076230-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076230-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076230-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076230-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076230-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076230-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076230-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076230-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076230-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076230-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076230-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076230-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076230-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076230-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076230-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076230-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076230-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076230-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076230-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076230-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076230-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076230-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076230-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076230-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076230-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076230-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076230-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lisinopril and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| LISINOPRIL | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0J48LPH2TH | Internal UNII lookup |
| E7199S1YWR | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197885 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ecac0280-6faa-e7f3-e053-2995a90a2bd9 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0207-3 | Lisinopril and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0207-3 | EA - Each | 80425-0207 | b494663f-ecc6-4748-b175-4604cf547dbe | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0207 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250101_ecac0280-6faa-e7f3-e053-2995a90a2bd9.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 |
|---|---|---|---|---|---|---|
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Proficient Rx LP | 84dba61d-cae2-4f21-9a9e-3088f356f838 | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | 076230 ANDA076230 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197885 | lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | ecac0280-6faa-e7f3-e053-2995a90a2bd9 | 3 |
| 197885 | hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral Tablet | SCD | ecac0280-6faa-e7f3-e053-2995a90a2bd9 | 3 |
| 197885 | HCTZ 12.5 MG / lisinopril 10 MG Oral Tablet | SY | ecac0280-6faa-e7f3-e053-2995a90a2bd9 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 80425-0207-3 | 80425020703 | 90 TABLET in 1 BOTTLE (80425-0207-3) | 90 tablet | 2022-11-04 | 0000-00-00 | No | No | Current |