Home NDC 70771-1117-0 ZYPITAMAG
Product NDC 70771-1117
Requested package NDC 70771-1117-0
11-digit product format 707711117
Labeler code 70771
Product ID 70771-1117_8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pitavastatin Magnesium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application NDA208379
Marketing category NDA
Marketing start 2018-03-09
Substance PITAVASTATIN
Active strength 2 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table 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# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table 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 table 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 table 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.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ZYPITAMAG
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PITAVASTATIN 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M5681Q5F9P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2001262 Internal RxNorm lookup 2001264 Internal RxNorm lookup 2001266 Internal RxNorm lookup 2001268 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 70771-1117-0 ZYPITAMAG 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8 70771-1117-1 ZYPITAMAG 100 in 1 BOTTLE TABLET, FILM COATED 100 8 70771-1117-3 ZYPITAMAG 30 in 1 BOTTLE TABLET, FILM COATED 30 8 70771-1117-4 ZYPITAMAG 10 in 1 CARTON TABLET, FILM COATED 10 8 70771-1117-4 ZYPITAMAG 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8 70771-1117-5 ZYPITAMAG 500 in 1 BOTTLE TABLET, FILM COATED 500 8 70771-1117-7 ZYPITAMAG 7 in 1 BLISTER PACK TABLET, FILM COATED 7 8 70771-1117-7 ZYPITAMAG 1 in 1 CARTON TABLET, FILM COATED 1 8 70771-1117-9 ZYPITAMAG 90 in 1 BOTTLE TABLET, FILM COATED 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1117 ZYPITAMAG (PITAVASTATIN MAGNESIUM) TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 8 Current NDC, Legacy NDC, 9 package rows 20240817_e9f0fe3a-0462-4c24-8f22-3c89afe8fcea.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70771-1117-0 70771111700 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1117-0) 2018-03-09 0000-00-00 No No Current