NDC 70771-1116
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 | 70771-1116_3acae750-43de-47a2-84b6-3e690ec4ee22 |
| NDC | 70771-1116 |
| 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 | 1 mg/1 |
| Pharm Classes | Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 70771-1116-9
90 TABLET, FILM COATED in 1 BOTTLE (70771-1116-9)
| Marketing Start Date | 2018-03-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70771-1116-4 [70771111604]
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 70771-1116-1 [70771111601]
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 70771-1116-5 [70771111605]
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 70771-1116-7 [70771111607]
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 70771-1116-9 [70771111609]
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 70771-1116-3 [70771111603]
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 70771-1116-0 [70771111600]
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 | 1 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 |
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