Sacubitril and Valsartan Tablets
- Manufacturer
- Zydus Lifesciences Limited
- Effective date
- 2025-07-08
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 21:37:03
Label at a glance#
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1656340 | sacubitril 24 MG / valsartan 26 MG Oral Tablet | PSN | 1 |
| 1656349 | sacubitril 49 MG / valsartan 51 MG Oral Tablet | PSN | 1 |
| 1656354 | sacubitril 97 MG / valsartan 103 MG Oral Tablet | PSN | 1 |
| 1656340 | sacubitril 24 MG / valsartan 26 MG Oral Tablet | SCD | 1 |
| 1656349 | sacubitril 49 MG / valsartan 51 MG Oral Tablet | SCD | 1 |
| 1656354 | sacubitril 97 MG / valsartan 103 MG Oral Tablet | SCD | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| SACUBITRILAT Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| VALSARTAN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 692a3434-fece-49c6-9b7d-ed7aefc52b50 | Product name | 3 | 20260317 |
| b15e9aa6-d523-ca97-480e-570e0543a342 | Product name | 4 | 20251024 |
| 265792b3-b999-c010-7364-a7db20b9d4d9 | Product name | 5 | 20250515 |
| e7dfdaab-7cf9-4f89-804c-eff5108d94d1 | Product name | 9 | 20250305 |
| b6abae2f-ee27-47bc-b150-54dc8d969483 | Product name | 2 | 20250221 |
| 52311e76-a520-4bd2-9d5b-e0b6d6f44519 | Product name | 2 | 20231208 |
| a8e65197-7914-7acf-c7ec-914d53819b34 | Product name | 3 | 20190624 |
| f5231d08-c52b-a5a0-ba93-675895c292be | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1921-2 | sacubitril and valsartan | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 70771-1921-4 | sacubitril and valsartan | 10 in 1 CARTON | TABLET | 10 | 1 | |
| 70771-1921-6 | sacubitril and valsartan | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 70771-1921-8 | sacubitril and valsartan | 180 in 1 BOTTLE | TABLET | 180 | 1 | |
| 70771-1922-2 | sacubitril and valsartan | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 70771-1922-4 | sacubitril and valsartan | 10 in 1 CARTON | TABLET | 10 | 1 | |
| 70771-1922-6 | sacubitril and valsartan | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 70771-1922-8 | sacubitril and valsartan | 180 in 1 BOTTLE | TABLET | 180 | 1 | |
| 70771-1923-2 | sacubitril and valsartan | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 70771-1923-4 | sacubitril and valsartan | 10 in 1 CARTON | TABLET | 10 | 1 | |
| 70771-1923-6 | sacubitril and valsartan | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 70771-1923-8 | sacubitril and valsartan | 180 in 1 BOTTLE | TABLET | 180 | 1 |
Products#
Every source-derived product name is available through these pages.
- sacubitril and valsartan
- SACUBITRIL
- SACUBITRILAT
- VALSARTAN
- CROSPOVIDONE (15 MPA.S AT 5%)
- HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
- HYPROMELLOSE 2910 (6 MPA.S)
- MICROCRYSTALLINE CELLULOSE 101
- MICROCRYSTALLINE CELLULOSE 102
- POLYETHYLENE GLYCOL 8000
- SILICON DIOXIDE
- SODIUM STEARYL FUMARATE
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- FERROSOFERRIC OXIDE
- ALUMINUM OXIDE
- FD&C BLUE NO. 2--ALUMINUM LAKE
- FD&C RED NO. 40
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1921 | 70771-1921-6, 70771-1921-8, 70771-1921-2, 70771-1921-4 |
| 70771-1922 | 70771-1922-6, 70771-1922-8, 70771-1922-2, 70771-1922-4 |
| 70771-1923 | 70771-1923-6, 70771-1923-8, 70771-1923-2, 70771-1923-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213719-001 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | |
| A213719-002 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | |
| A213719-003 | SACUBITRIL AND VALSARTAN | SACUBITRIL; VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213719-001 | AB |
| A213719-002 | AB |
| A213719-003 | 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 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213719-002 | SACUBITRIL AND VALSARTAN | 49MG;51MG | TABLET / ORAL | AB | 2024-07-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213719-003 | SACUBITRIL AND VALSARTAN | 97MG;103MG | TABLET / ORAL | AB | 2024-07-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213719-001 | SACUBITRIL AND VALSARTAN | 24MG;26MG | TABLET / ORAL | AB | 2024-07-09 | 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 | A213719-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213719-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A213719-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A213719-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213719-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213719-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213719-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213719-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213719-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213719-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213719-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213719-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213719-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213719-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213719-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213719-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213719-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213719-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213719-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213719-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213719-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213719-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213719-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213719-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213719-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213719-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213719-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213719-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213719-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213719-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213719-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213719-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213719-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213719-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213719-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213719-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213719-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213719-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213719-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213719-001 | AB | 1 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| sacubitril and valsartan | SACUBITRIL AND VALSARTAN | Zydus Lifesciences Limited | 4c871c01-0564-411f-87e2-478aa42503cf | 2025-07-08 | 70771-1923-6 70771-1923-4 70771-1921-4 70771-1921-6 70771-1921-2 70771-1923-2 70771-1922-2 70771-1921-8 70771-1922-6 70771-1923-8 70771-1922-4 70771-1922-8 70771-1921 70771-1923 70771-1922 70771192204 70771192306 70771192104 70771192304 70771192208 70771192302 70771192202 70771192102 70771192108 70771192206 70771192106 70771192308 f0d8c298-2823-4537-ae02-c43da2c66e67 4c871c01-0564-411f-87e2-478aa42503cf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


