Armodafinil
- Product NDC
- 69339-178
- 11-digit product format
- 693390178
- Labeler code
- 69339
- Product ID
- 69339-178_d93dca81-a0da-49ee-be61-86e713ab56cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Armodafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Natco Pharma USA LLC
- Application
- ANDA202768
- Marketing category
- ANDA
- Marketing start
- 2023-03-23
- Substance
- ARMODAFINIL
- Active strength
- 150 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Armodafinil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARMODAFINIL | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V63XWA605I |
| Rxcui | 724859, 724861, 724863, 861960 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69339-178-03 | Armodafinil | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 69339-178-10 | Armodafinil | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69339-178 | ARMODAFINIL TABLET [NATCO PHARMA USA LLC] | 2 | Current NDC, 2 package rows | 20240118_de2f0921-e791-426c-9192-2b7162e2158c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69339-178-03 | 69339017803 | 30 TABLET in 1 BOTTLE (69339-178-03) | 30 tablet | 2023-03-23 | No | No | Current |
| 69339-178-10 | 69339017810 | 1000 TABLET in 1 BOTTLE (69339-178-10) | 1000 tablet | 2023-03-23 | No | No | Current |