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NDC 00121-1350-00 VALPROIC ACID 500 mg/10mL Details
VALPROIC ACID 500 mg/10mL
VALPROIC ACID is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is VALPROIC ACID.
MedlinePlus Drug Summary
Valproic acid is used alone or with other medications to treat certain types of seizures. Valproic acid is also used to treat mania (episodes of frenzied, abnormally excited mood) in people with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). It is also used to prevent migraine headaches but not to relieve headaches that have already begun. Valproic acid is in a class of medications called anticonvulsants. It works by increasing the amount of a certain natural substance in the brain.
Related Packages: 00121-1350-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Valproic Acid
Product Information
| NDC | 00121-1350 |
|---|---|
| Product ID | 0121-1350_4eb69580-587f-49d9-bba5-de1a57302e0f |
| Associated GPIs | 72500020102060 |
| GCN Sequence Number | 068236 |
| GCN Sequence Number Description | valproic acid (as sodium salt) SOLUTION 500MG/10ML ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 30986 |
| HICL Sequence Number | 001882 |
| HICL Sequence Number Description | VALPROIC ACID (AS SODIUM SALT) (VALPROATE SODIUM) |
| Brand/Generic | Generic |
| Proprietary Name | VALPROIC ACID |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | VALPROIC ACID |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/10mL |
| Substance Name | VALPROIC ACID |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075379 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-1350-00 (00121135000)
| NDC Package Code | 0121-1350-00 |
|---|---|
| Billing NDC | 00121135000 |
| Package | 10 TRAY in 1 CASE (0121-1350-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1350-10) |
| Marketing Start Date | 2005-04-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |