FDA.reportPublic FDA data

NDC 16729-044-01 - 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
16729-044
Requested NDC
16729-044-01
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 82 of 147 · 2,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
unii: 15FIX9V2JP
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.b84d80c6-0240-4276-8e47-74a918f3d86a2025-08-12WarningsExact identifier
unii: H0G9379FGK
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
unii: 15FIX9V2JP
EmbrivaASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDEOncora Pharma, LLC3c362de4-1ed9-83be-e063-6394a90a10fc2025-08-12WarningsExact identifier
unii: H0G9379FGK
UP AND UP DUAL ACTION ACID REDUCER ANTACIDFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDETarget Corporation8e925e57-9036-4658-bf07-578e22675af82025-08-11WarningsExact identifier
unii: H0G9379FGK
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lbca57893-bd2d-44ac-a503-2f11c3b62bf22025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37188b77-ab0b-4bea-b839-99e589600a2b2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc89e45d6-2322-4913-a557-e1780a86fd632025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Acid Reducer Plus AntacidFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS Pharmacyd6f0b82c-3890-4e85-8b8a-354fb8d0b6402025-08-11WarningsExact identifier
unii: H0G9379FGK
Acid Reducer Plus AntacidFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECVS Pharmacy509435e4-14fd-4e09-bdc1-ad295b46806b2025-08-11WarningsExact identifier
unii: H0G9379FGK
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals, Inc.3bde7950-3d25-a86e-e063-6394a90ae6232025-08-08Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.4ff0d618-cde4-49ae-8bcb-98dafc3ecdba2025-08-08Warnings, Adverse reactionsExact identifier
rxcui: 617312
unii: 48A5M73Z4Q

Reported adverse events (FAERS/openFDA)#

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