VALPROIC ACID
- Product NDC
- 70518-3805
- 11-digit product format
- 705183805
- Labeler code
- 70518
- Product ID
- 70518-3805_3b298edc-34ee-b535-e063-6294a90a56f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VALPROIC ACID
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075379
- Marketing category
- ANDA
- Marketing start
- 2023-07-25
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VALPROIC ACID
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VALPROIC ACID | 250 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 614OI1Z5WI |
| Rxcui | 1099687 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3805-0 | VALPROIC ACID | 10 in 1 BOX | SOLUTION | 10 | | 4 |
| 70518-3805-1 | VALPROIC ACID | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 4 |
| 70518-3805-2 | VALPROIC ACID | 10 in 1 BOX | SOLUTION | 10 | | 4 |
| 70518-3805-3 | VALPROIC ACID | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3805 | VALPROIC ACID SOLUTION [REMEDYREPACK INC.] | 3 | Current NDC, 4 package rows | 20241127_65c1589e-c591-4b79-b75e-884c0d609ae8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3805-0 | 70518380500 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3805-0) / 5 mL in 1 CUP, UNIT-DOSE (70518-3805-1) | | 2023-07-25 | No | No | Historical |
| 70518-3805-1 | 70518380501 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 70518-3805-2 | 70518380502 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3805-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-3805-3) | | 2024-03-13 | No | No | Historical |
| 70518-3805-3 | 70518380503 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |