VIGABATRIN
- Product NDC
- 70377-089
- 11-digit product format
- 703770089
- Labeler code
- 70377
- Product ID
- 70377-089_81074a20-6150-469d-9293-22f31b25ff20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VIGABATRIN
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Biocon Pharma Inc.
- Application
- ANDA213390
- Marketing category
- ANDA
- Marketing start
- 2022-08-29
- Marketing end
- 0000-00-00
- Substance
- VIGABATRIN
- Active strength
- 500 mg/10mL
- Pharmacologic classes
- Anti-epileptic Agent [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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70377-089-01 | VIGABATRIN | 10 mL in 1 PACKET | POWDER, FOR SOLUTION | 10 | | 2 |
| 70377-089-01 | VIGABATRIN | 50 in 1 CARTON | POWDER, FOR SOLUTION | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-089 | VIGABATRIN POWDER, FOR SOLUTION [BIOCON PHARMA INC.] | 2 | Legacy NDC, 2 package rows | 20221111_663f447f-7b22-4e3e-942a-2df7713aa028.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 |
|---|
| 70377-089-01 | 70377008901 | 50 PACKET in 1 CARTON (70377-089-01) > 10 mL in 1 PACKET | 50 packet | 2022-08-29 | 0000-00-00 | No | No | Current |