Valproic acid
- Product NDC
- 50383-792
- 11-digit product format
- 503830792
- Labeler code
- 50383
- Product ID
- 50383-792_365491ba-2d9d-48b4-9014-ace7ad402433
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valproic acid
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Akorn
- 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
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VALPROIC ACID | ACTIVE INGREDIENT | 614OI1Z5WI | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| RASPBERRY | INACTIVE INGREDIENT | 4N14V5R27W | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] | 16 | |
| 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 table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-792 | VALPROIC ACID SOLUTION [AKORN] | 30 | Legacy NDC, 9 package rows | 20220916_84bbc23d-9bd3-4d48-9b64-d6eef64214b4.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 |
|---|
| 50383-792-05 | 50383079205 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 50383-792-06 | 50383079206 | 4 TRAY in 1 CASE (50383-792-06) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-792-05) | 4 tray | 2015-12-01 | 0000-00-00 | No | No | Current |
| 50383-792-07 | 50383079207 | 10 TRAY in 1 CASE (50383-792-07) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-792-05) | 10 tray | 2015-12-01 | 0000-00-00 | No | No | Current |
| 50383-792-10 | 50383079210 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | | Historical |
| 50383-792-12 | 50383079212 | 10 TRAY in 1 CASE (50383-792-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-792-10) | 10 tray | 2015-12-01 | 0000-00-00 | No | No | Current |
| 50383-792-16 | 50383079216 | 473 mL in 1 BOTTLE (50383-792-16) | 473 ml | 1995-01-13 | 0000-00-00 | No | No | Current |