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 91 of 147 · 2,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra strength AntacidCALCIUM CARBONATECVS HEALTH CORP2480eace-06a6-86a2-e063-6394a90a3c0c2025-03-15WarningsExact identifier
unii: H0G9379FGK
Extra Strength Assorted Fruit AntacidCALCIUM CARBONATEHarris Teeter, LLC2c51d1e6-fee2-c092-e063-6294a90acbe92025-03-14WarningsExact identifier
unii: H0G9379FGK
Supreme AntacidCALCIUM CARBONATE, MAGNESIUM HYDROXIDEH E B18a7dfd9-d927-7625-e063-6394a90a270f2025-03-14WarningsExact identifier
unii: H0G9379FGK
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Se-Natal 19 ChewableVITAMINS AND MINERALSSeton Pharmaceuticalsa54dd642-8884-415a-a082-cd9fb544e4002025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin calciumATORVASTATIN CALCIUMCoupler LLC2fffae44-e536-9645-e063-6394a90a7ce52025-03-10Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEDeMoulas Market Basketa7257be7-bef3-4fe7-8789-cc3da45168752025-03-05WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEDeMoulas Market Basket28bb40b6-8803-413e-846f-dedc3c0532762025-03-04WarningsExact identifier
unii: H0G9379FGK
Redicare Antacid Mint FlavoredREDICARE ANTACID MINT FLAVOREDRedicare LLC2f259f79-d321-5566-e063-6294a90a15222025-03-04WarningsExact identifier
unii: H0G9379FGK
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Assorted Berry AntacidCALCIUM CARBONATEDeMoulas Market Basket726c5e9f-55e6-416a-b001-0b56b05d7d1d2025-03-04WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Assorted FruitCALCIUM CARBONATEDeMoulas Market Basket9b07ad97-3f0f-401b-a855-6474b3dbdb692025-03-04WarningsExact identifier
unii: H0G9379FGK
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)2595385c-60ad-44e5-b3e3-1b9ac53044032025-02-28WarningsExact identifier
unii: H0G9379FGK
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Ultra Strength Antacid Wintergreen FlavorCALCIUM CARBONATE7-ELEVEN2f3c4e78-71d2-c46c-e063-6394a90a210a2025-02-28WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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