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#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70771-1116 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 70771-1116 | 70771-1116-0 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 70771-1116 | 70771-1116-1 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 70771-1116 | 70771-1116-3 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 70771-1116 | 70771-1116-4 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 70771-1116 | 70771-1116-5 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 70771-1116 | 70771-1116-7 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 70771-1116 | 70771-1116-9 | D | Discontinued by firm | 2026-09-14 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1116-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1116-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1116-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1116-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1116-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1116-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1116-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1116-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1116-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1116-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1116-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1116-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1116-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1116-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70771-1116-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70771-1116-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70771-1116-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70771-1116-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70771-1116-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70771-1116-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70771-1116-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70771-1116-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70771-1116-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70771-1116-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70771-1116-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70771-1116-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70771-1116-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70771-1116-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70771-1116-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70771-1116-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70771-1116-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70771-1116-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70771-1116-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70771-1116-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70771-1116-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70771-1116-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70771-1116-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70771-1116-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70771-1116-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70771-1116-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70771-1116-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70771-1116-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70771-1116-7 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70771-1116-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70771-1116-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70771-1116-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70771-1116-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70771-1116-9 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70771-1116-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70771-1116-7 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70771-1116-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70771-1116-4 | ed331223b511… | 672a5bd82f5f… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-002 | ZYPITAMAG | EQ 2MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-003 | ZYPITAMAG | EQ 4MG BASE | TABLET / ORAL | RLD, RS | 2017-07-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208379-001 | ZYPITAMAG | EQ 1MG BASE | TABLET / ORAL | RLD | 2017-07-14 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-002 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208379-003 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208379-001 | 8829186 | 2031-01-19 | Drug substance, Drug product | 2017-08-10 | 301d65b070ca… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 70771-1116-0 | 2021-07-08 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-1 | 2021-07-08 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-3 | 2021-07-08 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-4 | 2021-07-08 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-5 | 2021-07-08 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-7 | 2021-07-08 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-9 | 2021-07-08 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-0 | 2020-01-31 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-1 | 2020-01-31 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-3 | 2020-01-31 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-4 | 2020-01-31 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-5 | 2020-01-31 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-7 | 2020-01-31 | ZYPITAMAG (pitavastatin) tablets |
| 70771-1116-9 | 2020-01-31 | ZYPITAMAG (pitavastatin) tablets |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 |