ZYPITAMAG
- Product NDC
- 70771-1116
- 11-digit product format
- 707711116
- Labeler code
- 70771
- Product ID
- 70771-1116_3acae750-43de-47a2-84b6-3e690ec4ee22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pitavastatin Magnesium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cadila Healthcare Limited
- Application
- NDA208379
- Marketing category
- NDA
- Marketing start
- 2018-03-09
- Marketing end
- 0000-00-00
- Substance
- PITAVASTATIN
- Active strength
- 1 mg/1
- Pharmacologic classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70771-1116 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 70771-1116 | 70771-1116-0 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70771-1116 | 70771-1116-1 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70771-1116 | 70771-1116-3 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70771-1116 | 70771-1116-4 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70771-1116 | 70771-1116-5 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70771-1116 | 70771-1116-7 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70771-1116 | 70771-1116-9 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208379-001 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | |
| N208379-002 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | |
| N208379-003 | ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | |
| N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | |
| N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ZYPITAMAG | PITAVASTATIN MAGNESIUM | Medicure International Inc | c8c50e03-5cb8-43f4-bdef-8edd12f1945f | 2025-12-03 | Warnings, Adverse reactions | 208379 NDA208379 |
| ZYPITAMAG | PITAVASTATIN MAGNESIUM | Zydus Lifesciences Limited | e9f0fe3a-0462-4c24-8f22-3c89afe8fcea | 2024-08-14 | 208379 NDA208379 |