ropinirole hydrochloride
- Product NDC
- 63629-4798
- 11-digit product format
- 636294798
- Labeler code
- 63629
- Product ID
- 63629-4798_a77fe0b5-6a7f-413e-a6c9-952a1b2b1506
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078110
- Marketing category
- ANDA
- Marketing start
- 2011-09-20
- 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
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-4798-1 | 2024-01-30 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
| 63629-4798-2 | 2024-01-30 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
| 63629-4798-3 | 2024-01-30 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
| 63629-4798-4 | 2024-01-30 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
| 63629-4798-5 | 2024-01-30 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
| 63629-4798-1 | 2020-10-12 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
| 63629-4798-2 | 2020-10-12 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
| 63629-4798-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
| 63629-4798-2 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3726-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-4798-1 | ropinirole hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1006 |
| 63629-4798-2 | ropinirole hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1006 |
| 63629-4798-3 | ropinirole hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1006 |
| 63629-4798-4 | ropinirole hydrochloride | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 1006 |
| 63629-4798-5 | ropinirole hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1006 |
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 [BRYANT RANCH PREPACK] | 1001 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1001 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-4798 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1006 | Legacy NDC, 5 package rows | 20220505_8e23aac9-446c-43b5-89ab-fc596b766df0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-4798-1 | 63629479801 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-4798-1) | 2015-09-03 | 0000-00-00 | No | No | Current |
| 63629-4798-2 | 63629479802 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-4798-2) | 2013-03-29 | 0000-00-00 | No | No | Current |
| 63629-4798-3 | 63629479803 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-4798-3) | 2015-11-24 | 0000-00-00 | No | No | Current |
| 63629-4798-4 | 63629479804 | 28 TABLET, FILM COATED in 1 BOTTLE (63629-4798-4) | 2022-04-29 | 0000-00-00 | No | No | Current |
| 63629-4798-5 | 63629479805 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-4798-5) | 2018-02-28 | 0000-00-00 | No | No | Current |