Armodafinil
- Product NDC
- 65862-805
- 11-digit product format
- 658620805
- Labeler code
- 65862
- Product ID
- 65862-805_09746c0a-9656-4f1d-a380-1cbe732c8e21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Armodafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206069
- Marketing category
- ANDA
- Marketing start
- 2018-03-06
- Substance
- ARMODAFINIL
- Active strength
- 50 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 | 50 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 |
|---|
| 65862-805-05 | Armodafinil | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 65862-805-30 | Armodafinil | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 65862-805-60 | Armodafinil | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-805 | ARMODAFINIL TABLET [AUROBINDO PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240204_23da56b8-7552-4362-a1ab-e794c131194c.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 |
|---|
| 65862-805-05 | 65862080505 | 500 TABLET in 1 BOTTLE (65862-805-05) | 500 tablet | 2018-03-06 | 0000-00-00 | No | No | Current |
| 65862-805-30 | 65862080530 | 30 TABLET in 1 BOTTLE (65862-805-30) | 30 tablet | 2018-03-06 | 0000-00-00 | No | No | Current |
| 65862-805-60 | 65862080560 | 60 TABLET in 1 BOTTLE (65862-805-60) | 60 tablet | 2018-03-06 | 0000-00-00 | No | No | Current |