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 19 of 147 · 2,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAvPAKb687ba81-cb24-bbdf-5dd9-ab0e53dd480b2026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 617311
rxcui: 617310
rxcui: 259255
rxcui: 617312
Antacid MeltsCALCIUM CARBONATE 250MGQuest Products, LLC4dcc5323-eafe-0dc8-e063-6294a90acb602026-03-24WarningsExact identifier
unii: H0G9379FGK
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
GOOD SENSE DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEL. Perrigo Companyb5a36da3-7316-493c-b50f-fc5393d858c02026-03-24WarningsExact identifier
unii: H0G9379FGK
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
unii: 15FIX9V2JP
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepackbed1710f-edd9-488d-855b-603d50ee212c2026-03-20Warnings, Adverse reactionsExact identifier
unii: 48A5M73Z4Q
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.4a2bad30-e7cf-c48a-e063-6294a90a5f472026-03-20Warnings, Adverse reactionsExact identifier
rxcui: 259255
Extra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44eb8cf6-d8f0-0e08-e063-6394a90ac8ef2026-03-20WarningsExact identifier
unii: H0G9379FGK
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepackba6f6ab5-b65a-4486-b994-2d8bbbe650af2026-03-20Warnings, Adverse reactionsExact identifier
unii: 48A5M73Z4Q
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack5d7ca186-f22b-465f-913b-c020240b2c662026-03-20Warnings, Adverse reactionsExact identifier
unii: 48A5M73Z4Q
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack50112e22-5a69-47c9-90cd-82bbacae74182026-03-20Warnings, Adverse reactionsExact identifier
unii: 48A5M73Z4Q
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack9654e50b-811a-4c89-b1ab-f48418b204c12026-03-20Warnings, Adverse reactionsExact identifier
unii: 48A5M73Z4Q
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
unii: 15FIX9V2JP
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Companyb94b16d3-b52f-4d70-bbb0-d9fb074c891c2026-03-19WarningsExact identifier
unii: H0G9379FGK
Extra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.44657e4a-6093-bcab-e063-6394a90a48372026-03-19WarningsExact identifier
unii: H0G9379FGK
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.f7bb4aac-f716-4dd9-a6d7-6f37e865b8432026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 617312
unii: 48A5M73Z4Q
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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