Ropinirole
- Product NDC
- 13811-639
- 11-digit product format
- 138110639
- Labeler code
- 13811
- Product ID
- 13811-639_4d6c8925-b701-4ab9-bd50-a83c999cb157
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropinirole
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Trigen Laboratories, LLC
- Application
- ANDA202786
- Marketing category
- ANDA
- Marketing start
- 2013-03-14
- Marketing end
- 2021-02-28
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13811-639-01 | 13811063901 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-639-01) | 2013-03-14 | 2021-02-28 | No | No | Current |
| 13811-639-10 | 13811063910 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-639-10) | 2013-03-14 | 2021-02-28 | No | No | Current |
| 13811-639-11 | 13811063911 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (13811-639-11) | 2013-03-14 | 2021-02-28 | No | No | Current |
| 13811-639-30 | 13811063930 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-639-30) | 2013-03-14 | 2021-02-28 | No | No | Current |
| 13811-639-50 | 13811063950 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-639-50) | 2013-03-14 | 2021-02-28 | No | No | Current |
| 13811-639-90 | 13811063990 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-639-90) | 2013-03-14 | 2021-02-28 | No | No | Current |