NDC 16729-045-01 - 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
16729-045
Requested NDC
16729-045-01
Package NDCs from labels
16729-045-10, 16729-045-15, 16729-045-01, 16729-045-16, 16729-045-17
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2025-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
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 - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2023-03-31HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2023-01-03HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Proficient Rx LPProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Quality Care Products, LLCQuality Care Products, LLC2021-09-22HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-06-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-045-01ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED10013
16729-045-10ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED3013
16729-045-15ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED9013
16729-045-16ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED50013
16729-045-17ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-045ATORVASTATIN 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
16729-045-15EA - Each16729-045ec800b59-eb53-4816-ab9d-7ff42a9cb5ef12021-06-02
16729-045-17EA - Each16729-045d79f8df8-c45e-4468-97c7-9884a2fcd53012018-08-13

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 119 of 145 · 2,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
unii: H0G9379FGK
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.fa2d8d38-dbd0-43fd-e053-6294a90a4e942024-05-13Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
Equaline Ultra Strength Antacid Assorted Berry Ultra strength Assorted Fruit AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI3e18b19f-063c-4d6e-9bf2-4fdc04e640892024-05-12WarningsExact identifier
unii: H0G9379FGK
EQU Ultra Strength Antacid Assorted Fruit 171AFCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI8cfe3fe3-99fa-44ae-a68e-8c8e97e231772024-05-12WarningsExact identifier
unii: H0G9379FGK
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
unii: 15FIX9V2JP
Prenatol-MMULTIVITAMINPureTek Corporation17559a44-94b7-9ca0-e063-6294a90a21232024-05-06Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Tums Chewy Bites PeppermintCALCIUM CARBONATEHaleon US Holdings LLC45a44b2b-1633-49c5-8c55-9e9af3545c922024-05-03WarningsExact identifier
unii: H0G9379FGK
Equqline Extra Strength Antacid Assorted FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI270c35f6-8ce2-4e88-940b-a02a749817582024-05-01WarningsExact identifier
unii: H0G9379FGK
Equaline Extra Strength Assorted Berry AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI61d2e663-f0cf-4c14-a4f0-09897c760b132024-05-01WarningsExact identifier
unii: H0G9379FGK
Guardian Extra Strength Smooth Alkum Antacid 173bfCALCIUM CARBONATEGuardian Drug Companyae324739-8497-47aa-9e68-cbe42dfd83012024-05-01WarningsExact identifier
unii: H0G9379FGK
Atorvastatin calciumATORVASTATIN CALCIUMLifestar Pharma LLCde8f2c55-44d2-4e01-b7f2-dfb24f1f87602024-04-30Warnings, Adverse reactionsExact identifier
rxcui: 617311
rxcui: 617310
rxcui: 259255
rxcui: 617312
unii: 48A5M73Z4Q
EQUALINE Regular Strength Antacid PeppermintCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFIea361a6e-70b6-42b9-b64c-05d5d038cf6a2024-04-30WarningsExact identifier
unii: H0G9379FGK
Guardian Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEGuardian Drug Company0579de6c-8c25-4b7c-9184-1f73537fc2312024-04-29WarningsExact identifier
unii: H0G9379FGK
Equqline Regular Strength AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFIaae36cef-404b-4bb0-b107-58140c4ab8912024-04-28WarningsExact identifier
unii: H0G9379FGK
ATORVALIQATORVALIQCMP Pharma, Inc.41fca2d8-7f3f-45b9-8974-81b89accc2112024-04-27Warnings, Adverse reactionsExact identifier
unii: 48A5M73Z4Q

Reported adverse events (FAERS/openFDA)#

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