Valsartan
- Product NDC
- 43547-368
- 11-digit product format
- 435470368
- Labeler code
- 43547
- Product ID
- 43547-368_bd8fb4f2-9d4a-4cf3-8b9e-cc5ba34bcea1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA204821
- Marketing category
- ANDA
- Marketing start
- 2015-08-31
- Substance
- VALSARTAN
- Active strength
- 80 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204821-001 | VALSARTAN | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | |
| A204821-002 | VALSARTAN | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | |
| A204821-003 | VALSARTAN | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | |
| A204821-004 | VALSARTAN | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204821-001 | AB |
| A204821-002 | AB |
| A204821-003 | AB |
| A204821-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204821-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204821-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204821-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204821-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-06-09 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204821-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204821-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204821-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204821-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204821-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204821-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204821-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204821-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204821-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204821-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204821-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204821-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204821-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204821-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204821-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204821-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204821-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204821-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204821-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204821-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204821-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204821-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204821-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204821-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204821-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204821-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204821-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204821-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204821-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204821-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204821-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204821-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204821-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204821-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204821-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204821-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204821-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204821-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204821-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204821-004 | AB | 1 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Valsartan
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VALSARTAN | 80 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 80M03YXJ7I | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 26080940-bcd3-446d-9026-3ddfb58e281e | Available on FDA.report |
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 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| a8e65197-7914-7acf-c7ec-914d53819b34 | Product name | 3 | 20190624 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| f5231d08-c52b-a5a0-ba93-675895c292be | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-368-03 | Valsartan | 30 in 1 BOTTLE | TABLET | 30 | 13 | |
| 43547-368-09 | Valsartan | 90 in 1 BOTTLE | TABLET | 90 | 13 | |
| 43547-368-11 | Valsartan | 1000 in 1 BOTTLE | TABLET | 1000 | 13 | |
| 43547-368-50 | Valsartan | 500 in 1 BOTTLE | TABLET | 500 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-368-09 | EA - Each | 43547-368 | 01d1a83a-49df-4e23-a6d9-51b0abc3a3b2 | 1 | 2015-10-02 |
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 |
|---|---|---|---|---|---|---|
| Valsartan | VALSARTAN | A-S Medication Solutions | d9af6ba1-c760-4af6-b733-88e4892d4cb6 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 |
| Valsartan | VALSARTAN | Northwind Health Company, LLC | 03af7d09-314a-fe85-e063-6294a90afa25 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 |
| Valsartan | VALSARTAN | Solco Healthcare US, LLC | 26080940-bcd3-446d-9026-3ddfb58e281e | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 43547-368 |
| Valsartan | VALSARTAN | A-S Medication Solutions | 2847db2a-fcc9-4776-875a-ba6d57d5ea8b | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 |
| Valsartan | VALSARTAN | Bryant Ranch Prepack | d9a16816-d4de-401a-8413-7233f4e541f8 | 2024-01-16 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 |
| Valsartan | VALSARTAN | Bryant Ranch Prepack | e8fcd4c2-8baa-452a-b723-5cb3d8d203a9 | 2023-12-14 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 |
| Valsartan | VALSARTAN | Bryant Ranch Prepack | 4e160647-a08e-40e8-b566-3e97a09c616a | 2023-11-22 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 |
| Valsartan | VALSARTAN | Bryant Ranch Prepack | bcbd44f6-d49a-4a59-bba5-70fb843d1f59 | 2023-09-25 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 |
| Valsartan | VALSARTAN | Proficient Rx LP | b58471fe-e2c6-4cc5-9d49-6a3111f6e002 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 204821 ANDA204821 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-368-03 | 43547036803 | 30 TABLET in 1 BOTTLE (43547-368-03) | 30 tablet | 2015-08-31 | 0000-00-00 | No | No | Current |
| 43547-368-09 | 43547036809 | 90 TABLET in 1 BOTTLE (43547-368-09) | 90 tablet | 2015-08-31 | 0000-00-00 | No | No | Current |
| 43547-368-11 | 43547036811 | 1000 TABLET in 1 BOTTLE (43547-368-11) | 1000 tablet | 2015-08-31 | 0000-00-00 | No | No | Current |
| 43547-368-50 | 43547036850 | 500 TABLET in 1 BOTTLE (43547-368-50) | 500 tablet | 2015-08-31 | 0000-00-00 | No | No | Current |