NDC 70771-1117
ZYPITAMAG
Pitavastatin Magnesium
ZYPITAMAG is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Pitavastatin.
| Product ID | 70771-1117_3686984a-2614-4b26-a8ff-1126829b40f3 |
| NDC | 70771-1117 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ZYPITAMAG |
| Generic Name | Pitavastatin Magnesium |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-03-09 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208379 |
| Labeler Name | Cadila Healthcare Limited |
| Substance Name | PITAVASTATIN |
| Active Ingredient Strength | 2 mg/1 |
| Pharm Classes | Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 70771-1117-0
1000 TABLET, FILM COATED in 1 BOTTLE (70771-1117-0)
| Marketing Start Date | 2018-03-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70771-1117-9 [70771111709]
ZYPITAMAG TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208379 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-09 |
| Inactivation Date | 2020-01-31 |
NDC 70771-1117-3 [70771111703]
ZYPITAMAG TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208379 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-09 |
| Inactivation Date | 2020-01-31 |
NDC 70771-1117-0 [70771111700]
ZYPITAMAG TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208379 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-09 |
| Inactivation Date | 2020-01-31 |
NDC 70771-1117-4 [70771111704]
ZYPITAMAG TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208379 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-09 |
| Inactivation Date | 2020-01-31 |
NDC 70771-1117-5 [70771111705]
ZYPITAMAG TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208379 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-09 |
| Inactivation Date | 2020-01-31 |
NDC 70771-1117-1 [70771111701]
ZYPITAMAG TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208379 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-09 |
| Inactivation Date | 2020-01-31 |
NDC 70771-1117-7 [70771111707]
ZYPITAMAG TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208379 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-09 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PITAVASTATIN | 2 mg/1 |
OpenFDA Data
| SPL SET ID: | e9f0fe3a-0462-4c24-8f22-3c89afe8fcea |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- HMG-CoA Reductase Inhibitor [EPC]
NDC Crossover Matching brand name "ZYPITAMAG" or generic name "Pitavastatin Magnesium"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 25208-200 | ZYPITAMAG | Pitavastatin Magnesium |
| 25208-201 | ZYPITAMAG | Pitavastatin Magnesium |
| 25208-202 | ZYPITAMAG | Pitavastatin Magnesium |
| 70771-1116 | ZYPITAMAG | Pitavastatin Magnesium |
| 70771-1117 | ZYPITAMAG | Pitavastatin Magnesium |
| 70771-1118 | ZYPITAMAG | Pitavastatin Magnesium |
Trademark Results [ZYPITAMAG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZYPITAMAG 87730057 not registered Live/Pending |
Cadila Healthcare Limited 2017-12-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.