Valproic Acid
- Product NDC
- 67544-479
- 11-digit product format
- 675440479
- Labeler code
- 67544
- Product ID
- 67544-479_4c40fbad-f018-45a5-813f-5a7dca18c9a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- valproic acid
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA073229
- Marketing category
- ANDA
- Marketing start
- 1991-10-29
- Marketing end
- 0000-00-00
- Substance
- VALPROIC ACID
- Active strength
- 250 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67544-479-32 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b5e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Valproic Acid Capsules, USP safely and effectively. See full prescribing information for Valproic Acid Capsules, USP. Valproic Acid Capsules, USP for Oral use Initial U.S. Approval: 1978 |
| 67544-479-53 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b5e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Valproic Acid Capsules, USP safely and effectively. See full prescribing information for Valproic Acid Capsules, USP. Valproic Acid Capsules, USP for Oral use Initial U.S. Approval: 1978 |
| 67544-479-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b5e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Valproic Acid Capsules, USP safely and effectively. See full prescribing information for Valproic Acid Capsules, USP. Valproic Acid Capsules, USP for Oral use Initial U.S. Approval: 1978 |
| 67544-479-70 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b5e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Valproic Acid Capsules, USP safely and effectively. See full prescribing information for Valproic Acid Capsules, USP. Valproic Acid Capsules, USP for Oral use Initial U.S. Approval: 1978 |
| 67544-479-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b5e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Valproic Acid Capsules, USP safely and effectively. See full prescribing information for Valproic Acid Capsules, USP. Valproic Acid Capsules, USP for Oral use Initial U.S. Approval: 1978 |
| 67544-479-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b5e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Valproic Acid Capsules, USP safely and effectively. See full prescribing information for Valproic Acid Capsules, USP. Valproic Acid Capsules, USP for Oral use Initial U.S. Approval: 1978 |
| 67544-479-94 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b5e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Valproic Acid Capsules, USP safely and effectively. See full prescribing information for Valproic Acid Capsules, USP. Valproic Acid Capsules, USP for Oral use Initial U.S. Approval: 1978 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67544-479-32 | Valproic Acid | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 1 |
| 67544-479-53 | Valproic Acid | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 1 |
| 67544-479-60 | Valproic Acid | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 1 |
| 67544-479-70 | Valproic Acid | 120 in 1 BOTTLE, PLASTIC | CAPSULE | 120 | | 1 |
| 67544-479-80 | Valproic Acid | 180 in 1 BOTTLE, PLASTIC | CAPSULE | 180 | | 1 |
| 67544-479-90 | Valproic Acid | 240 in 1 BOTTLE, PLASTIC | CAPSULE | 240 | | 1 |
| 67544-479-94 | Valproic Acid | 360 in 1 BOTTLE, PLASTIC | CAPSULE | 360 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-479 | VALPROIC ACID CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 7 package rows | 20140410_002d4c7e-b94e-49b6-8554-0aa0c60d5bde.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67544-479-32 | 67544047932 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 67544-479-53 | 67544047953 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 67544-479-60 | 67544047960 | 90 in 1 BOTTLE, PLASTIC | Historical |
| 67544-479-70 | 67544047970 | 120 in 1 BOTTLE, PLASTIC | Historical |
| 67544-479-80 | 67544047980 | 180 in 1 BOTTLE, PLASTIC | Historical |
| 67544-479-90 | 67544047990 | 240 in 1 BOTTLE, PLASTIC | Historical |
| 67544-479-94 | 67544047994 | 360 in 1 BOTTLE, PLASTIC | Historical |