Armodafinil
- Product NDC
- 71335-0710
- 11-digit product format
- 713350710
- Labeler code
- 71335
- Product ID
- 71335-0710_d8558bc2-6354-454a-81e9-3fad93f276f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Armodafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA200751
- Marketing category
- ANDA
- Marketing start
- 2016-11-28
- Marketing end
- 0000-00-00
- Substance
- ARMODAFINIL
- Active strength
- 250 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 71335-0710 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 71335-0710 | 71335-0710-1 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 71335-0710 | 71335-0710-2 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 71335-0710 | 71335-0710-3 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A200751-001 | ARMODAFINIL | ARMODAFINIL | 50MG | TABLET / ORAL | | | 2016-11-28 |
| A200751-003 | ARMODAFINIL | ARMODAFINIL | 150MG | TABLET / ORAL | | | 2016-11-28 |
| A200751-004 | ARMODAFINIL | ARMODAFINIL | 200MG | TABLET / ORAL | | | 2016-11-28 |
| A200751-005 | ARMODAFINIL | ARMODAFINIL | 250MG | TABLET / ORAL | | | 2016-11-28 |
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-0710-1 | 2020-06-14 | C162847 | 48780-1 | 9d75b9d0-cbfb-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 |
| 71335-0710-2 | 2020-06-14 | C162847 | 48780-1 | 9d75b9d0-cbfb-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 |
| 71335-0710-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cbfb-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 |
| 71335-0710-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cbfb-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-0710-1 | 71335071001 | 30 TABLET in 1 BOTTLE (71335-0710-1) | 30 tablet | 2018-03-02 | 0000-00-00 | No | No | Current |
| 71335-0710-2 | 71335071002 | 28 TABLET in 1 BOTTLE (71335-0710-2) | 28 tablet | 2018-03-02 | 0000-00-00 | No | No | Current |
| 71335-0710-3 | 71335071003 | 90 TABLET in 1 BOTTLE (71335-0710-3) | 90 tablet | 2018-03-02 | 0000-00-00 | No | No | Current |