Valproate Sodium
- Product NDC
- 63323-494
- 11-digit product format
- 633230494
- Labeler code
- 63323
- Product ID
- 63323-494_f09a2148-edd9-4918-8359-7554ed263d3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VALPROATE SODIUM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA076539
- Marketing category
- ANDA
- Marketing start
- 2003-08-18
- Substance
- VALPROATE SODIUM
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Valproate Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VALPROATE SODIUM | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5VOM6GYJ0D |
| Rxcui | 1099648 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-494-01 | Valproate Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 11 |
| 63323-494-05 | Valproate Sodium | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 11 |
| 63323-494-16 | Valproate Sodium | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 6 |
| 63323-494-41 | Valproate Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VALPROATE SODIUM | ACTIVE INGREDIENT | 5VOM6GYJ0D | VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-494 | VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241206_c572ece7-03d3-4c2a-aeb5-61f2023b28ea.zip |
| 63323-494 | VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250202_3dfb6da1-f66a-4618-9f74-d2d6c16c0b58.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-494-01 | 63323049401 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 63323-494-05 | 63323049405 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-01) | | 2003-08-18 | 0000-00-00 | No | No | Current |
| 63323-494-16 | 63323049416 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-16) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41) | | 2003-08-18 | 0000-00-00 | No | No | Current |
| 63323-494-41 | 63323049441 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |