ropinirole hydrochloride
- Product NDC
- 21695-793
- 11-digit product format
- 216950793
- Labeler code
- 21695
- Product ID
- 21695-793_88c5b939-a658-4972-b849-e5c00a447b53
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA090429
- Marketing category
- ANDA
- Marketing start
- 2009-09-18
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 21695-793-60 | ropinirole hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROPINIROLE HYDROCHLORIDE | ACTIVE INGREDIENT | D7ZD41RZI9 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-793 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110706_88c5b939-a658-4972-b849-e5c00a447b53.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-793-60 | 21695079360 | 60 in 1 BOTTLE | Historical |