Armodafinil
- Product NDC
- 68180-572
- 11-digit product format
- 681800572
- Labeler code
- 68180
- Product ID
- 68180-572_b4c0895d-90c6-4624-98fb-978e2c2893e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Armodafinil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA200751
- Marketing category
- ANDA
- Marketing start
- 2016-11-28
- Marketing end
- 0000-00-00
- Substance
- ARMODAFINIL
- Active strength
- 200 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 | 68180-572 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 68180-572 | 68180-572-02 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 68180-572 | 68180-572-07 | 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-572-02 | 68180057202 | 500 TABLET in 1 BOTTLE (68180-572-02) | 500 tablet | 2016-11-28 | 0000-00-00 | No | No | Current |
| 68180-572-07 | 68180057207 | 60 TABLET in 1 BOTTLE (68180-572-07) | 60 tablet | 2016-11-28 | 0000-00-00 | No | No | Current |