FDA.reportPublic FDA data

Atorvastatin Calcium

Manufacturer
Northwind Pharmaceuticals
Effective date
2014-04-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:36:27

Label at a glance#

ProductAtorvastatin Calcium
Active ingredientATORVASTATIN CALCIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:51655-880-30

MFG: 0591-3777-19

Atorvastatin Calcium 80 mg

30 tablets

RX only

Dosage: See package insert

Store at 68 to 77 degrees F

Keep out of the reach of children.

Each tablet contains: Atorvastatin Calcium USP 80mg

Mfg By: Pfizer Pharmaceuticals, Puerto Rico

Repackaged by Northwind Pharmaceuticals Indianapolis, IN 46256

Lot # NW30930001

Exp Date: 09/2015

Atorvastatin 80mgAtorvastatin 80mg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-880-302026-01-13C16284748780-19d75b9d1-0024-f424-e053-dadaa90a57ce2881210e-b0d8-44a1-8540-d7cb985b89b9
51655-880-302020-01-31C16284748780-19d75b9d1-0024-f424-e053-dadaa90a57ce2881210e-b0d8-44a1-8540-d7cb985b89b9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-880ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140429_2881210e-b0d8-44a1-8540-d7cb985b89b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3777-05EA - Each0591-37779970bdb4-1ff5-4585-a895-3532600cdbe612012-07-24
0591-3777-19EA - Each0591-3777054ab947-97d8-40fa-a2b9-a9bf68e9ef4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4Q1
ATORVASTATINACTIVE MOIETYA0JWA85V8F1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51655-88051655-880-30
0591-3777

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATORVASTATIN CALCIUM48A5M73Z4QACTIM

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47e55317-547d-b30e-e063-6294a90abde12881210e-b0d8-44a1-8540-d7cb985b89b92026-01-08Exact identifier
spl set id: 2881210e-b0d8-44a1-8540-d7cb985b89b9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.