Valsartan

Product NDC
71335-0600
11-digit product format
713350600
Labeler code
71335
Product ID
71335-0600_3d3425ce-596a-483e-82e9-24a9e6d09f50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090642
Marketing category
ANDA
Marketing start
2015-01-05
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0600DDiscontinued by firm2026-08-17
excluded packagepackage71335-060071335-0600-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-060071335-0600-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-060071335-0600-3DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0600-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0600-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0600-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0600-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0600-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0600-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0600-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0600-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0600-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0600-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0600-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0600-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0600-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0600-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0600-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0600-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0600-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0600-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0600-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0600-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0600-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0600-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0600-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0600-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0600-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0600-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0600-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0600-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0600-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0600-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0600-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0600-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0600-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0600-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0600-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0600-1557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090642-001VALSARTANVALSARTAN40MGTABLET / ORAL2015-01-05
A090642-002VALSARTANVALSARTAN80MGTABLET / ORAL2015-01-05
A090642-003VALSARTANVALSARTAN160MGTABLET / ORAL2015-01-05
A090642-004VALSARTANVALSARTAN320MGTABLET / ORAL2015-01-05

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090642-001VALSARTAN40MGTABLET / ORAL2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090642-002VALSARTAN80MGTABLET / ORAL2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090642-003VALSARTAN160MGTABLET / ORAL2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090642-004VALSARTAN320MGTABLET / ORAL2015-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090642-001VALSARTAN40MGTABLET / ORAL2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090642-002VALSARTAN80MGTABLET / ORAL2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090642-003VALSARTAN160MGTABLET / ORAL2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090642-004VALSARTAN320MGTABLET / ORAL2015-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090642-001VALSARTAN40MGTABLET / ORAL2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090642-002VALSARTAN80MGTABLET / ORAL2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090642-003VALSARTAN160MGTABLET / ORAL2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090642-004VALSARTAN320MGTABLET / ORAL2015-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090642-001VALSARTAN40MGTABLET / ORAL2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090642-002VALSARTAN80MGTABLET / ORAL2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090642-003VALSARTAN160MGTABLET / ORAL2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090642-004VALSARTAN320MGTABLET / ORAL2015-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090642-001VALSARTAN40MGTABLET / ORAL2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090642-002VALSARTAN80MGTABLET / ORAL2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090642-003VALSARTAN160MGTABLET / ORAL2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090642-004VALSARTAN320MGTABLET / ORAL2015-01-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090642-001VALSARTAN40MGTABLET / ORAL2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090642-002VALSARTAN80MGTABLET / ORAL2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090642-003VALSARTAN160MGTABLET / ORAL2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090642-004VALSARTAN320MGTABLET / ORAL2015-01-05d8e5a09893c0…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0600-1EA - Each71335-0600d51180bd-06b0-4020-bd88-546f6af3bee412018-03-08
71335-0600-2EA - Each71335-0600fd581b81-8f92-428a-8a6a-444c70ef752112018-03-08
71335-0600-3EA - Each71335-06005b874c01-ffd8-4a33-9079-349a6501558012018-03-08