FDA.reportPublic FDA data

Valproic Acid

Product NDC
62135-196
11-digit product format
621350196
Labeler code
62135
Product ID
62135-196_5071bcb9-2d2f-24e3-e063-6294a90a8e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA075782
Marketing category
ANDA
Marketing start
2000-12-22
Substance
VALPROIC ACID
Active strength
250 mg/5mL
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [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 1.

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
A075782-001VALPROIC ACIDVALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075782-001AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A075782-001VALPROIC ACID250MG/5MLSYRUP / ORAL2000-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075782-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075782-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075782-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075782-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075782-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075782-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075782-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075782-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075782-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075782-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075782-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075782-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075782-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075782-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075782-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075782-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075782-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075782-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075782-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075782-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075782-001AA187673890dc5c…
2020-12-22 03:56 UTC2020-12A075782-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075782-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075782-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A075782-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075782-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075782-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075782-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075782-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075782-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075782-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075782-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075782-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075782-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075782-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075782-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075782-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075782-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075782-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075782-001AA1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALPROIC ACID250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
614OI1Z5WIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099687Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8051ad62-3b6e-461e-8090-60f5c0a904f4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-196-24Valproic Acid10 in 1 TRAYSOLUTION104
62135-196-24Valproic Acid2 in 1 BOXSOLUTION24
62135-196-45Valproic Acid5 mL in 1 CUPSOLUTION54
62135-196-47Valproic Acid473 mL in 1 BOTTLESOLUTION4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-196-24ML - Milliliter62135-19616bbb570-a6cc-4a42-849b-762316aab0e012024-09-09
62135-196-45ML - Milliliter62135-1969e087550-6357-4200-9a62-abb59e8d78f112024-09-09
62135-196-47ML - Milliliter62135-19665e6c282-feea-425e-80f8-9fc655ac4c0c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-196VALPROIC ACID SOLUTION [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 4 package rows20240601_8051ad62-3b6e-461e-8090-60f5c0a904f4.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
Valproic AcidVALPROIC ACIDChartwell RX, LLC8051ad62-3b6e-461e-8090-60f5c0a904f42026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075782
application number: ANDA075782
ndc (product): 62135-196
Valproic AcidVALPROIC ACIDChartwell Governmental & Specialty RX, LLC.5d19f389-7180-4e01-845f-519b7ea60ba02025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075782
application number: ANDA075782

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099687valproic acid 250 MG in 5 mL Oral SolutionPSN8051ad62-3b6e-461e-8090-60f5c0a904f44
1099687valproic acid 50 MG/ML Oral SolutionSCD8051ad62-3b6e-461e-8090-60f5c0a904f44
1099687valproate sodium 50 MG/ML SyrupSY8051ad62-3b6e-461e-8090-60f5c0a904f44
1099687valproic acid 250 MG per 5 ML Oral SolutionSY8051ad62-3b6e-461e-8090-60f5c0a904f44
1099687valproic acid 500 MG per 10 ML Oral SolutionSY8051ad62-3b6e-461e-8090-60f5c0a904f44
1099687VPA 50 MG/ML Oral SolutionSY8051ad62-3b6e-461e-8090-60f5c0a904f44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-196-24621350196242 TRAY in 1 BOX (62135-196-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45) 2 tray2024-05-28NoNoCurrent
62135-196-45621350196455 mL in 1 CUP5 mlHistorical
62135-196-4762135019647473 mL in 1 BOTTLE (62135-196-47) 473 ml2022-08-150000-00-00NoNoCurrent