VALPROIC ACID
- Product NDC
- 0121-1350
- 11-digit product format
- 001211350
- Labeler code
- 0121
- Product ID
- 0121-1350_8c4404f6-81d2-4211-b6b9-5e8d1f497dd6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VALPROIC ACID
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA075379
- Marketing category
- ANDA
- Marketing start
- 2005-04-11
- Substance
- VALPROIC ACID
- Active strength
- 500 mg/10mL
- 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 | 500 mg/10mL |
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 |
|---|
| 0121-1350-00 | VALPROIC ACID | 10 in 1 TRAY | SOLUTION | 10 | | 21 |
| 0121-1350-00 | VALPROIC ACID | 10 in 1 CASE | SOLUTION | 10 | | 21 |
| 0121-1350-10 | VALPROIC ACID | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VALPROIC ACID | ACTIVE INGREDIENT | 614OI1Z5WI | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | VALPROIC ACID SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-1350 | VALPROIC ACID SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 21 | Current NDC, Legacy NDC, 3 package rows | 20250205_7d5cb52e-37dd-4dfa-a6f4-09f9548846c6.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 |
|---|
| 0121-1350-00 | 00121135000 | 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) | 10 tray | 2005-04-11 | 0000-00-00 | No | No | Current |
| 0121-1350-10 | 00121135010 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | | Historical |