Valproic Acid
- Product NDC
- 17856-0792
- 11-digit product format
- 178560792
- Labeler code
- 17856
- Product ID
- 17856-0792_ecfe5102-f404-416a-a0c1-a798f9446642
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valproic Acid
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- Application
- ANDA074060
- Marketing category
- ANDA
- Marketing start
- 1995-01-13
- Marketing end
- 0000-00-00
- 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
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b10a892b-b985-4cbc-9547-9ac4b72b784f | Product name | 2 | 20250818 |
| 7a3a03f1-382a-f9ec-0741-ff24dcbfed69 | Product name | 7 | 20250624 |
| 57fc3d01-4737-4091-9728-9e8a4c9e708d | Product name | 1 | 20200121 |
| 5d67ecc7-47c7-ec5e-e9eb-71bf00250645 | Product name | 1 | 20140508 |
| 97fce1a8-50c4-f088-0e31-64d82b6e9081 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0792-2 | 2026-01-29 | C162847 | 48780-1 | 9d75b9d0-47f2-f424-e053-dadaa90a57ce | Valproic Acid Oral Solution, USP |
| 17856-0792-6 | 2026-01-29 | C162847 | 48780-1 | 9d75b9d0-47f2-f424-e053-dadaa90a57ce | Valproic Acid Oral Solution, USP |
| 17856-0792-1 | 2023-02-02 | C162847 | 48780-1 | 9d75b9d0-47f2-f424-e053-dadaa90a57ce | Valproic Acid Oral Solution, USP |
| 17856-0792-5 | 2023-02-02 | C162847 | 48780-1 | 9d75b9d0-47f2-f424-e053-dadaa90a57ce | Valproic Acid Oral Solution, USP |
| 17856-0792-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-47f2-f424-e053-dadaa90a57ce | Valproic Acid Oral Solution, USP |
| 17856-0792-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-47f2-f424-e053-dadaa90a57ce | Valproic Acid Oral Solution, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0792-1 | Valproic Acid | 10 mL in 1 CUP | SOLUTION | 10 | 6 | |
| 17856-0792-2 | Valproic Acid | 72 in 1 BOX, UNIT-DOSE | SOLUTION | 72 | 6 | |
| 17856-0792-5 | Valproic Acid | 5 mL in 1 CUP | SOLUTION | 5 | 6 | |
| 17856-0792-6 | Valproic Acid | 72 in 1 BOX, UNIT-DOSE | SOLUTION | 72 | 6 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| VALPROIC ACID | ACTIVE INGREDIENT | 614OI1Z5WI | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| RASPBERRY | INACTIVE INGREDIENT | 4N14V5R27W | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0792 | VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 6 | Legacy NDC, 4 package rows | 20240517_dce4388c-d663-4829-afa2-2329f0172245.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1099687 | valproic acid 250 MG in 5 mL Oral Solution | PSN | dce4388c-d663-4829-afa2-2329f0172245 | 6 |
| 1099687 | valproic acid 50 MG/ML Oral Solution | SCD | dce4388c-d663-4829-afa2-2329f0172245 | 6 |
| 1099687 | valproate sodium 50 MG/ML Syrup | SY | dce4388c-d663-4829-afa2-2329f0172245 | 6 |
| 1099687 | valproic acid 250 MG per 5 ML Oral Solution | SY | dce4388c-d663-4829-afa2-2329f0172245 | 6 |
| 1099687 | valproic acid 500 MG per 10 ML Oral Solution | SY | dce4388c-d663-4829-afa2-2329f0172245 | 6 |
| 1099687 | VPA 50 MG/ML Oral Solution | SY | dce4388c-d663-4829-afa2-2329f0172245 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 17856-0792-1 | 17856079201 | 10 mL in 1 CUP | 10 ml | Historical |
| 17856-0792-2 | 17856079202 | 72 in 1 BOX, UNIT-DOSE | Historical | |
| 17856-0792-5 | 17856079205 | 5 mL in 1 CUP | 5 ml | Historical |
| 17856-0792-6 | 17856079206 | 72 in 1 BOX, UNIT-DOSE | Historical |