ropinirole hydrochloride
- Product NDC
- 65841-718
- 11-digit product format
- 658410718
- Labeler code
- 65841
- Product ID
- 65841-718_82436c19-cab1-4857-9a7d-9e32e4ba0f72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA090411
- Marketing category
- ANDA
- Marketing start
- 2009-09-23
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 [CADILA HEALTHCARE LIMITED] | 3 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| COCHINEAL | INACTIVE INGREDIENT | TZ8Z31B35M | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-718 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 7 | Legacy NDC | 20221109_5525c364-3574-4029-89dc-1efc6d85c03c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-718-01 | 65841071801 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-718-01) | 2009-09-23 | 0000-00-00 | No | No | Current |
| 65841-718-10 | 65841071810 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-718-10) | 2009-09-23 | 0000-00-00 | No | No | Current |