ROPINIROLE HYDROCHLORIDE
- Product NDC
- 42291-714
- 11-digit product format
- 422910714
- Labeler code
- 42291
- Product ID
- 42291-714_2b47ad1c-e1cb-7b8b-e063-6394a90aee3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA090869
- Marketing category
- ANDA
- Marketing start
- 2013-09-13
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ROPINIROLE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROPINIROLE HYDROCHLORIDE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7ZD41RZI9 |
| Rxcui | 799054, 799055, 799056, 824959, 848582 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-714-30 | ROPINIROLE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 6 |
| 42291-714-90 | ROPINIROLE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROPINIROLE HYDROCHLORIDE | ACTIVE INGREDIENT | D7ZD41RZI9 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Castor Oil | INACTIVE INGREDIENT | D5340Y2I9G | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Fd&c Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Fd&c Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Ferric Oxide Yellow | INACTIVE INGREDIENT | EX438O2MRT | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Polyvinyl Alcohol | INACTIVE INGREDIENT | 532B59J990 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
| Triacetin | INACTIVE INGREDIENT | XHX3C3X673 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-714 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AVKARE] | 6 | Current NDC, 2 package rows | 20250112_abd344d9-7635-62a2-d4e1-38fc46937397.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-714-30 | 42291071430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-714-30) | 2023-11-01 | No | No | Historical |
| 42291-714-90 | 42291071490 | 90 in 1 BOTTLE | | | | Historical |