Valsartan

Product NDC
43547-367
11-digit product format
435470367
Labeler code
43547
Product ID
43547-367_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
40 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

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
A204821-001VALSARTANVALSARTAN40MGTABLET / ORALAB2015-06-09
A204821-002VALSARTANVALSARTAN80MGTABLET / ORALAB2015-06-09
A204821-003VALSARTANVALSARTAN160MGTABLET / ORALAB2015-06-09
A204821-004VALSARTANVALSARTAN320MGTABLET / ORALAB2015-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204821-001AB
A204821-002AB
A204821-003AB
A204821-004AB

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 06:07:402026-07A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204821-001VALSARTAN40MGTABLET / ORALAB2015-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204821-002VALSARTAN80MGTABLET / ORALAB2015-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204821-003VALSARTAN160MGTABLET / ORALAB2015-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204821-004VALSARTAN320MGTABLET / ORALAB2015-06-09d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204821-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204821-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204821-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204821-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204821-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204821-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204821-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204821-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204821-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204821-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204821-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204821-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204821-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204821-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204821-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204821-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204821-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204821-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204821-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204821-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204821-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204821-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204821-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204821-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204821-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204821-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204821-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204821-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204821-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204821-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204821-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204821-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204821-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204821-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204821-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204821-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204821-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204821-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204821-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204821-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Valsartan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80M03YXJ7IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349199Internal RxNorm lookup
349200Internal RxNorm lookup
349201Internal RxNorm lookup
349483Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
26080940-bcd3-446d-9026-3ddfb58e281eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-367-03Valsartan30 in 1 BOTTLETABLET3013
43547-367-09Valsartan90 in 1 BOTTLETABLET9013
43547-367-11Valsartan1000 in 1 BOTTLETABLET100013
43547-367-50Valsartan500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-367-03EA - Each43547-3674b552871-567e-4e52-a28f-e4ab065a8c0e12015-10-02
43547-367-09EA - Each43547-367b4556c60-25d1-49e5-8761-6e38886c6e8812023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-367VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]11Current NDC, Legacy NDC, 4 package rows20250427_26080940-bcd3-446d-9026-3ddfb58e281e.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.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValsartanVALSARTANA-S Medication Solutionsd9af6ba1-c760-4af6-b733-88e4892d4cb62026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821
ValsartanVALSARTANNorthwind Health Company, LLC03af7d09-314a-fe85-e063-6294a90afa252026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821
ValsartanVALSARTANSolco Healthcare US, LLC26080940-bcd3-446d-9026-3ddfb58e281e2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821
ndc (product): 43547-367
ValsartanVALSARTANA-S Medication Solutions2847db2a-fcc9-4776-875a-ba6d57d5ea8b2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821
ValsartanVALSARTANBryant Ranch Prepackd9a16816-d4de-401a-8413-7233f4e541f82024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821
ValsartanVALSARTANBryant Ranch Prepacke8fcd4c2-8baa-452a-b723-5cb3d8d203a92023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821
ValsartanVALSARTANBryant Ranch Prepack4e160647-a08e-40e8-b566-3e97a09c616a2023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821
ValsartanVALSARTANBryant Ranch Prepackbcbd44f6-d49a-4a59-bba5-70fb843d1f592023-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821
ValsartanVALSARTANProficient Rx LPb58471fe-e2c6-4cc5-9d49-6a3111f6e0022021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204821
application number: ANDA204821

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349483valsartan 40 MG Oral TabletPSNe8fcd4c2-8baa-452a-b723-5cb3d8d203a9100
349483valsartan 40 MG Oral TabletSCDe8fcd4c2-8baa-452a-b723-5cb3d8d203a9100
349201valsartan 160 MG Oral TabletPSN26080940-bcd3-446d-9026-3ddfb58e281e13
349200valsartan 320 MG Oral TabletPSN26080940-bcd3-446d-9026-3ddfb58e281e13
349483valsartan 40 MG Oral TabletPSN26080940-bcd3-446d-9026-3ddfb58e281e13
349199valsartan 80 MG Oral TabletPSN26080940-bcd3-446d-9026-3ddfb58e281e13
349201valsartan 160 MG Oral TabletSCD26080940-bcd3-446d-9026-3ddfb58e281e13
349200valsartan 320 MG Oral TabletSCD26080940-bcd3-446d-9026-3ddfb58e281e13
349483valsartan 40 MG Oral TabletSCD26080940-bcd3-446d-9026-3ddfb58e281e13
349199valsartan 80 MG Oral TabletSCD26080940-bcd3-446d-9026-3ddfb58e281e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-367-034354703670330 TABLET in 1 BOTTLE (43547-367-03) 30 tablet2015-08-310000-00-00NoNoCurrent
43547-367-094354703670990 TABLET in 1 BOTTLE (43547-367-09) 90 tablet2015-08-310000-00-00NoNoCurrent
43547-367-11435470367111000 TABLET in 1 BOTTLE (43547-367-11) 1000 tablet2015-08-310000-00-00NoNoCurrent
43547-367-5043547036750500 TABLET in 1 BOTTLE (43547-367-50) 500 tablet2015-08-310000-00-00NoNoCurrent