FDA.reportPublic FDA data

Valproic Acid

Product NDC
0116-4021
11-digit product format
001164021
Labeler code
0116
Product ID
0116-4021_4459a233-1fe1-41dc-e063-6394a90a5ab4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Xttrium Laboratories Inc.
Application
ANDA070868
Marketing category
ANDA
Marketing start
1986-07-01
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
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
0116-4021-05Valproic Acid5 mL in 1 CUP, UNIT-DOSESOLUTION52
0116-4021-10Valproic Acid10 mL in 1 CUP, UNIT-DOSESOLUTION102
0116-4021-11Valproic Acid10 in 1 CASESOLUTION102
0116-4021-11Valproic Acid10 in 1 TRAYSOLUTION102
0116-4021-16Valproic Acid473 mL in 1 BOTTLE, PLASTICSOLUTION4732
0116-4021-40Valproic Acid4 in 1 CASESOLUTION42
0116-4021-40Valproic Acid10 in 1 TRAYSOLUTION102
0116-4021-41Valproic Acid10 in 1 TRAYSOLUTION102
0116-4021-41Valproic Acid10 in 1 CASESOLUTION102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099687valproic acid 250 MG in 5 mL Oral SolutionPSN3b124a29-30bd-d30e-e063-6294a90ac4ca2
1099687valproic acid 50 MG/ML Oral SolutionSCD3b124a29-30bd-d30e-e063-6294a90ac4ca2
1099687valproate sodium 50 MG/ML SyrupSY3b124a29-30bd-d30e-e063-6294a90ac4ca2
1099687valproic acid 250 MG per 5 ML Oral SolutionSY3b124a29-30bd-d30e-e063-6294a90ac4ca2
1099687valproic acid 500 MG per 10 ML Oral SolutionSY3b124a29-30bd-d30e-e063-6294a90ac4ca2
1099687VPA 50 MG/ML Oral SolutionSY3b124a29-30bd-d30e-e063-6294a90ac4ca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0116-4021-05001164021055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0116-4021-100011640211010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
0116-4021-110011640211110 TRAY in 1 CASE (0116-4021-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4021-10) 10 tray2025-07-29NoNoHistorical
0116-4021-1600116402116473 mL in 1 BOTTLE, PLASTIC (0116-4021-16) 473 ml2025-07-29NoNoHistorical
0116-4021-40001164021404 TRAY in 1 CASE (0116-4021-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05) 4 tray2025-07-29NoNoHistorical
0116-4021-410011640214110 TRAY in 1 CASE (0116-4021-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05) 10 tray2025-07-29NoNoHistorical