ropinirole
- Product NDC
- 68258-7163
- 11-digit product format
- 682587163
- Labeler code
- 68258
- Product ID
- 68258-7163_c5dd57e1-930a-4942-97ac-2b63f1d9a7f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA090135
- Marketing category
- ANDA
- Marketing start
- 2010-02-25
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 2 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 |
|---|
| 68258-7163-3 | ropinirole | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROPINIROLE HYDROCHLORIDE | ACTIVE INGREDIENT | D7ZD41RZI9 | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-7163 | ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 3 | Legacy NDC, 1 package rows | 20130803_caa8f322-325d-4117-a564-c87391ebf6fe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68258-7163-3 | 68258716303 | 30 in 1 BOTTLE | Historical |