valsartan
- Product NDC
- 59746-363
- 11-digit product format
- 597460363
- Labeler code
- 59746
- Product ID
- 59746-363_9c828bee-09d3-4021-99e7-e5fd3e83741c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmacuticals Inc.
- Application
- ANDA203536
- Marketing category
- ANDA
- Marketing start
- 2015-01-05
- Substance
- VALSARTAN
- Active strength
- 320 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [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 |
|---|---|---|---|---|---|---|---|
| A203536-001 | VALSARTAN | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | |
| A203536-002 | VALSARTAN | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | |
| A203536-003 | VALSARTAN | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | |
| A203536-004 | VALSARTAN | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203536-001 | AB |
| A203536-002 | AB |
| A203536-003 | AB |
| A203536-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203536-001 | VALSARTAN | 40MG | TABLET / ORAL | AB | 2015-01-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203536-002 | VALSARTAN | 80MG | TABLET / ORAL | AB | 2015-01-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203536-003 | VALSARTAN | 160MG | TABLET / ORAL | AB | 2015-01-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203536-004 | VALSARTAN | 320MG | TABLET / ORAL | AB | 2015-01-05 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203536-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203536-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203536-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203536-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203536-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203536-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203536-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203536-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203536-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203536-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203536-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203536-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203536-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203536-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203536-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203536-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203536-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203536-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203536-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203536-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203536-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203536-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203536-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203536-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203536-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203536-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203536-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203536-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203536-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203536-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203536-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203536-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203536-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203536-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203536-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203536-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203536-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203536-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203536-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203536-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- valsartan
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VALSARTAN | 320 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 80M03YXJ7I | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9402b022-5809-4251-dfef-54f6ef5723fe | 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 |
| a8e65197-7914-7acf-c7ec-914d53819b34 | Product name | 3 | 20190624 |
| f5231d08-c52b-a5a0-ba93-675895c292be | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59746-363-30 | valsartan | 30 in 1 BOTTLE | TABLET | 30 | 9 | |
| 59746-363-32 | valsartan | 10 in 1 BLISTER PACK | TABLET | 10 | 9 | |
| 59746-363-32 | valsartan | 3 in 1 CARTON | TABLET | 3 | 9 | |
| 59746-363-67 | valsartan | 400 in 1 BOTTLE | TABLET | 400 | 9 | |
| 59746-363-90 | valsartan | 90 in 1 BOTTLE | TABLET | 90 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59746-363-90 | EA - Each | 59746-363 | 88996d70-f848-4a4b-9a9b-0ace6a4da53c | 1 | 2015-02-02 |
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 | Northwind Health Company, LLC | db4801e5-6e0f-2cb3-e053-2995a90a709a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 203536 ANDA203536 |
| valsartan | VALSARTAN | PD-Rx Pharmaceuticals, Inc. | 5afd7c3d-c66b-479c-bfd0-6c04658b157d | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203536 ANDA203536 |
| valsartan | VALSARTAN | Jubilant Cadista Pharmacuticals Inc. | 9402b022-5809-4251-dfef-54f6ef5723fe | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | 203536 ANDA203536 59746-363 |
| valsartan | VALSARTAN | A-S Medication Solutions | 80987771-ccb4-4a9f-a395-0af4c2621e0a | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | 203536 ANDA203536 |
| valsartan | VALSARTAN | A-S Medication Solutions | e352db8b-0485-492a-8734-0a415566d764 | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | 203536 ANDA203536 |
| valsartan | VALSARTAN | A-S Medication Solutions | 9f5a400f-9cfc-4d25-a677-73cbb14375e2 | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | 203536 ANDA203536 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349201 | valsartan 160 MG Oral Tablet | PSN | 9402b022-5809-4251-dfef-54f6ef5723fe | 9 |
| 349200 | valsartan 320 MG Oral Tablet | PSN | 9402b022-5809-4251-dfef-54f6ef5723fe | 9 |
| 349483 | valsartan 40 MG Oral Tablet | PSN | 9402b022-5809-4251-dfef-54f6ef5723fe | 9 |
| 349199 | valsartan 80 MG Oral Tablet | PSN | 9402b022-5809-4251-dfef-54f6ef5723fe | 9 |
| 349201 | valsartan 160 MG Oral Tablet | SCD | 9402b022-5809-4251-dfef-54f6ef5723fe | 9 |
| 349200 | valsartan 320 MG Oral Tablet | SCD | 9402b022-5809-4251-dfef-54f6ef5723fe | 9 |
| 349483 | valsartan 40 MG Oral Tablet | SCD | 9402b022-5809-4251-dfef-54f6ef5723fe | 9 |
| 349199 | valsartan 80 MG Oral Tablet | SCD | 9402b022-5809-4251-dfef-54f6ef5723fe | 9 |
| 349200 | valsartan 320 MG Oral Tablet | PSN | 80987771-ccb4-4a9f-a395-0af4c2621e0a | 5 |
| 349200 | valsartan 320 MG Oral Tablet | SCD | 80987771-ccb4-4a9f-a395-0af4c2621e0a | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59746-363-30 | 59746036330 | 30 TABLET in 1 BOTTLE (59746-363-30) | 30 tablet | 2015-01-05 | 0000-00-00 | No | No | Current |
| 59746-363-32 | 59746036332 | 3 BLISTER PACK in 1 CARTON (59746-363-32) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2015-01-05 | 0000-00-00 | No | No | Current |
| 59746-363-67 | 59746036367 | 400 TABLET in 1 BOTTLE (59746-363-67) | 400 tablet | 2015-01-05 | 0000-00-00 | No | No | Current |
| 59746-363-90 | 59746036390 | 90 TABLET in 1 BOTTLE (59746-363-90) | 90 tablet | 2015-01-05 | 0000-00-00 | No | No | Current |