FDA.reportPublic FDA data

NDC 16729-044-16 - ATORVASTATIN CALCIUM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
16729-044
Requested NDC
16729-044-16
Package NDCs from labels
16729-044-10, 16729-044-15, 16729-044-01, 16729-044-16, 16729-044-17
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-03-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ATORVASTATIN CALCIUM - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2026-03-05HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2025-10-06HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Bryant Ranch PrepackBryant Ranch Prepack2024-10-31HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-20HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - REMEDYREPACK INC.REMEDYREPACK INC.2024-02-23HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2023-03-31HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Proficient Rx LPProficient Rx LP2022-05-01HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Quality Care Products, LLCQuality Care Products, LLC2021-09-22HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - A-S Medication SolutionsA-S Medication Solutions2021-05-18HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2020-12-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-044-01ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED10013
16729-044-10ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED3013
16729-044-15ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED9013
16729-044-16ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED50013
16729-044-17ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-044ATORVASTATIN CALCIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]12Current NDC, Legacy NDC, 5 package rows20241004_4e06b20d-cc5d-46eb-991b-5972248de3af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-044-15EA - Each16729-0448059a8d9-db16-41e7-958d-afce0d8378cd12021-06-02
16729-044-17EA - Each16729-044f9b79a87-df9c-4ff9-a50b-8381c28bfd4c12018-08-13

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 64 of 145 · 2,883 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutions811e6733-fa82-4b41-b426-fe24aa70e6012025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
CVS Tropical FruitANTACIDCVS321fce7a-90be-45f2-b3a5-6b92d4f6ddb32025-12-04WarningsExact identifier
unii: H0G9379FGK
Quality Choice Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Marketing Associationc1171d19-5694-4e6c-9865-40c5f62c4f052025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Antacid Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONbfb80841-edda-482b-b401-e5f1cd52440e2025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Regular Strength Peppermint FlavorCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONea1abf51-7d10-4b1f-8eca-c5f94892bfe72025-12-03WarningsExact identifier
unii: H0G9379FGK
QC Regular StrengthANTACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)1dd6df9a-241b-4a85-b31a-0741e916ae462025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Assorted Berries Extra StrengthCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONc7f26b0a-f2c4-4ed2-9673-52f90d1a41c92025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Extra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION639b39b5-44e0-4bba-8887-ce62cfac68372025-12-03WarningsExact identifier
unii: H0G9379FGK
QC Antacid Calcium Assorted BerryCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.82f5e540-a1b2-48e2-9b1d-ff52c29f78352025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Ultra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION63318b46-d47d-474c-8fb5-5e0d53b7adb42025-12-03WarningsExact identifier
unii: H0G9379FGK
calcium antacidextra strength extra strengthCALCIUM CARBONATERugby Laboratoriesd761954f-940e-4833-87b7-173a921aade12025-12-03WarningsExact identifier
unii: H0G9379FGK
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma, Inc.d8a72abf-1d43-47e1-88e8-c3c5cc4ba1632025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 617311
Equate Ultra Stregth AntacidCALCIUM CARBONATEWal-Mart Stores, Inc.cdfe5c95-3f90-4620-a618-18bac0471c3e2025-12-03WarningsExact identifier
unii: H0G9379FGK
D-CALCALCIUM CARBONATEA&Z Pharmaceutical Inc.4c202dae-1ad8-44ab-a272-bdca808453022025-12-01WarningsExact identifier
unii: H0G9379FGK
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.bd216f5d-f319-7d8d-e053-2a95a90aa9ce2025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.c0e2a5d0-1aa3-e131-e053-2a95a90a98702025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
Antacid Regular StrengthANTACIDWALGREEN CO.ce5eef7f-497d-4c88-be6a-17eeb6e07f5b2025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Extra StrengthANTACIDWALGREEN CO.2981c5f7-121a-4030-86b1-559061030e7a2025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Extra StrengthANTACID CALCIUM CARBONATEWALGREEN CO.14baa410-6ce3-4ddb-aac7-e2172d1506c42025-11-25WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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