Ropinirole Hydrochloride
- Product NDC
- 64220-421
- 11-digit product format
- 642200421
- Labeler code
- 64220
- Product ID
- 64220-421_db5b7681-1e06-4ff2-a0c1-5304b298f0f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropinirole Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zhejiang Huahai Pharmaceutical Co., Ltd.
- Application
- ANDA078110
- Marketing category
- ANDA
- Marketing start
- 2011-08-10
- 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 |
|---|
| 64220-421-01 | Ropinirole Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 64220-421-02 | Ropinirole Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
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 [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| ROPINIROLE | ACTIVE MOIETY | 030PYR8953 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64220-421 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.] | 2 | Legacy NDC, 2 package rows | 20110916_6f7fc849-8a38-47a1-bc39-54801a86416c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 64220-421-01 | 64220042101 | 100 in 1 BOTTLE | Historical |
| 64220-421-02 | 64220042102 | 500 in 1 BOTTLE | Historical |