Home NDC 65862-812 Pitavastatin
Product NDC 65862-812
11-digit product format 658620812
Labeler code 65862
Product ID 65862-812_9a71c5a7-aaf8-4650-aba4-da6ba84d03a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pitavastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA206015
Marketing category ANDA
Marketing start 2023-11-02
Substance PITAVASTATIN CALCIUM
Active strength 1 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 A206015-001 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 A206015-002 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 A206015-003 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Pitavastatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PITAVASTATIN CALCIUM 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IYD54XEG3W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861643 Internal RxNorm lookup 861648 Internal RxNorm lookup 861652 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-812-05 Pitavastatin 500 in 1 BOTTLE TABLET, FILM COATED 500 6 65862-812-90 Pitavastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-812 PITAVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 Current NDC, 2 package rows 20240425_a52401eb-a822-475b-a40d-7b8acde2ae1a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65862-812-05 65862081205 500 TABLET, FILM COATED in 1 BOTTLE (65862-812-05) 2023-11-02 No No Current 65862-812-90 65862081290 90 TABLET, FILM COATED in 1 BOTTLE (65862-812-90) 2023-11-02 No No Current