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

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 Identifiers#

Field, Values table
FieldValues
Unii614OI1Z5WI
Rxcui1099687

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

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 tray2024-05-28NoNoHistorical
62135-196-45621350196455 mL in 1 CUP5 mlHistorical
62135-196-4762135019647473 mL in 1 BOTTLE (62135-196-47) 473 ml2022-08-150000-00-00NoNoCurrent