Valsartan

Product NDC
72336-910
11-digit product format
723360910
Labeler code
72336
Product ID
72336-910_dd4cbd3f-572e-400b-8fe7-98d537557b80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
SOLUTION
Route
ORAL
Labeler
Lifsa Drugs LLC
Application
ANDA214102
Marketing category
ANDA
Marketing start
2022-04-04
Substance
VALSARTAN
Active strength
4 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214102-001VALSARTANVALSARTAN4MG/MLSOLUTION / ORALABRS2021-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214102-001AB

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214102-001VALSARTAN4MG/MLSOLUTION / ORALABRS2021-11-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214102-001VALSARTAN4MG/MLSOLUTION / ORALABRS2021-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214102-001VALSARTAN4MG/MLSOLUTION / ORALABRS2021-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A214102-001VALSARTAN4MG/MLSOLUTION / ORALABRS2021-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-02782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A214102-001VALSARTAN20MG/5MLSOLUTION / ORALRS2021-11-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214102-001VALSARTAN20MG/5MLSOLUTION / ORAL2021-11-02cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214102-001VALSARTAN4MG/MLSOLUTION / ORALABRS2021-11-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214102-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214102-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214102-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214102-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214102-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN4 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1996254Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
130e1659-9c2d-49ca-9db8-d28aa23fd133Available 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
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72336-910-79Valsartan120 mL in 1 BOTTLE, PLASTICSOLUTION1201
72336-910-89Valsartan473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72336-910-79ML - Milliliter72336-9104014a2e3-4f87-45c3-9ec3-4183f3a3852b12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72336-910VALSARTAN SOLUTION [LIFSA DRUGS LLC]1Current NDC, Legacy NDC, 2 package rows20220414_130e1659-9c2d-49ca-9db8-d28aa23fd133.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValsartanVALSARTANANI Pharmaceuticals, Inc.959b6790-feb7-45a9-9ea4-0ee1a7fce0482023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214102
application number: ANDA214102
ValsartanVALSARTANLifsa Drugs LLC130e1659-9c2d-49ca-9db8-d28aa23fd1332022-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214102
application number: ANDA214102
ndc (product): 72336-910

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996254valsartan 20 MG in 5 mL Oral SolutionPSN130e1659-9c2d-49ca-9db8-d28aa23fd1331
1996254valsartan 4 MG/ML Oral SolutionSCD130e1659-9c2d-49ca-9db8-d28aa23fd1331
1996254valsartan 20 MG in 5 mL Oral SolutionSY130e1659-9c2d-49ca-9db8-d28aa23fd1331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72336-910-7972336091079120 mL in 1 BOTTLE, PLASTIC (72336-910-79) 120 ml2022-04-040000-00-00NoNoCurrent
72336-910-8972336091089473 mL in 1 BOTTLE, PLASTIC (72336-910-89) 473 ml2022-04-040000-00-00NoNoCurrent