Valsartan

Product NDC
31722-746
11-digit product format
317220746
Labeler code
31722
Product ID
31722-746_2b44fd7a-fd5a-984d-e063-6294a90a3fff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203311
Marketing category
ANDA
Marketing start
2015-01-05
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
2026-12-31
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
A203311-001VALSARTANVALSARTAN40MGTABLET / ORALAB2015-01-05
A203311-002VALSARTANVALSARTAN80MGTABLET / ORALAB2015-01-05
A203311-003VALSARTANVALSARTAN160MGTABLET / ORALAB2015-01-05
A203311-004VALSARTANVALSARTAN320MGTABLET / ORALAB2015-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203311-001AB
A203311-002AB
A203311-003AB
A203311-004AB

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 06:07:402026-07A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203311-001VALSARTAN40MGTABLET / ORALAB2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203311-002VALSARTAN80MGTABLET / ORALAB2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203311-003VALSARTAN160MGTABLET / ORALAB2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203311-004VALSARTAN320MGTABLET / ORALAB2015-01-05d8e5a09893c0…

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 06:07:402026-07A203311-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203311-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203311-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203311-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203311-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203311-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203311-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203311-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203311-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203311-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203311-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203311-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203311-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203311-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203311-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203311-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203311-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203311-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203311-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203311-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203311-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203311-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203311-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203311-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203311-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203311-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203311-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203311-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203311-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203311-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203311-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203311-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203311-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203311-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203311-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203311-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203311-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203311-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203311-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203311-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Valsartan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN80 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
0ff36e83-b307-42db-a2ab-bae3f6805c20Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-746-05Valsartan500 in 1 BOTTLETABLET, FILM COATED5008
31722-746-30Valsartan30 in 1 BOTTLETABLET, FILM COATED308
31722-746-31Valsartan10 in 1 BLISTER PACKTABLET, FILM COATED108
31722-746-32Valsartan100 in 1 BLISTER PACKTABLET, FILM COATED1008
31722-746-90Valsartan90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-746-90EA - Each31722-7468ceda9c9-90d9-466c-8828-67908f4bc3a612015-02-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-746VALSARTAN (VALSARTAN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 5 package rows20250112_0ff36e83-b307-42db-a2ab-bae3f6805c20.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValsartanVALSARTANNorthwind Health Company, LLC04b3301f-e054-ed5d-e063-6294a90a819c2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANBryant Ranch Prepack6e9c4c57-e2c9-461b-9c09-669d3ada4c1a2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANBryant Ranch Prepackc12db287-786c-47ae-a1f3-df04ddfd2a702026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANBryant Ranch Prepackb3880f58-ce15-4701-84aa-8eb185cf43e22026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANBryant Ranch Prepack7b523502-62b3-425e-960b-f0a58919d3ec2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANA-S Medication Solutions0925a24f-6a72-4c77-b4e6-0a8f5b12c8d02026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANCamber Pharmaceuticals, Inc.d6e84105-9394-4ef0-928c-20d07d3fbaa92026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANNorthwind Health Company, LLCf756009f-f04f-6518-e053-6294a90a79ed2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANCoupler LLC3eee9505-ebba-76e3-e063-6294a90acd6e2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANCoupler LLC3dfe5407-96a6-d2f4-e063-6294a90aa8102025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANProficient Rx LPf59f71d3-c143-43e5-ac22-0b1d741f4a812025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANCamber Pharmaceuticals, Inc.0ff36e83-b307-42db-a2ab-bae3f6805c202025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ndc (product): 31722-746
ValsartanVALSARTANAvPAK0878f27e-5368-c93f-e063-6394a90a10862025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANA-S Medication Solutions688b5c82-2eba-445c-869e-60609f5db86a2023-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311
ValsartanVALSARTANA-S Medication Solutions506ab3dd-c5eb-4755-ad10-bc116f4443c72023-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203311
application number: ANDA203311

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN0ff36e83-b307-42db-a2ab-bae3f6805c208
349200valsartan 320 MG Oral TabletPSN0ff36e83-b307-42db-a2ab-bae3f6805c208
349483valsartan 40 MG Oral TabletPSN0ff36e83-b307-42db-a2ab-bae3f6805c208
349199valsartan 80 MG Oral TabletPSN0ff36e83-b307-42db-a2ab-bae3f6805c208
349201valsartan 160 MG Oral TabletSCD0ff36e83-b307-42db-a2ab-bae3f6805c208
349200valsartan 320 MG Oral TabletSCD0ff36e83-b307-42db-a2ab-bae3f6805c208
349483valsartan 40 MG Oral TabletSCD0ff36e83-b307-42db-a2ab-bae3f6805c208
349199valsartan 80 MG Oral TabletSCD0ff36e83-b307-42db-a2ab-bae3f6805c208

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-746-0531722074605500 TABLET, FILM COATED in 1 BOTTLE (31722-746-05) 2015-01-050000-00-00NoNoCurrent
31722-746-303172207463030 TABLET, FILM COATED in 1 BOTTLE (31722-746-30) 2015-01-050000-00-00NoNoCurrent
31722-746-313172207463110 TABLET, FILM COATED in 1 BLISTER PACK (31722-746-31) 2015-01-050000-00-00NoNoCurrent
31722-746-3231722074632100 TABLET, FILM COATED in 1 BLISTER PACK (31722-746-32) 2015-01-050000-00-00NoNoCurrent
31722-746-903172207469090 TABLET, FILM COATED in 1 BOTTLE (31722-746-90) 2015-01-050000-00-00NoNoCurrent