Ropinirole Hydrochloride
- Product NDC
- 53217-166
- 11-digit product format
- 532170166
- Labeler code
- 53217
- Product ID
- 53217-166_7d48c7ff-6157-431e-bde8-8aa48d6de24a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropinirole Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA090429
- Marketing category
- ANDA
- Marketing start
- 2009-09-18
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 0 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-166-30 | Ropinirole Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 53217-166-60 | Ropinirole Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-166 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 2 package rows | 20150327_b11ca8cb-289c-4015-84b3-be905de46aff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-166-30 | 53217016630 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 53217-166-60 | 53217016660 | 60 in 1 BOTTLE, PLASTIC | Historical |