FDA.reportPublic FDA data

NDC 16729-047-01 - 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
16729-047
Requested NDC
16729-047-01
Package NDCs from labels
16729-047-10, 16729-047-15, 16729-047-01, 16729-047-16, 16729-047-17
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 - A-S Medication SolutionsA-S Medication Solutions2022-08-25HUMAN PRESCRIPTION DRUG LABEL
ATORVASTATIN CALCIUM - Bryant Ranch PrepackBryant Ranch Prepack2022-02-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-047-01ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED10013
16729-047-10ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED3013
16729-047-15ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED9013
16729-047-16ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED50013
16729-047-17ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-047ATORVASTATIN 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
16729-047-15EA - Each16729-047010cdd35-4a9f-46cb-9e88-e9b995a916e412021-06-02
16729-047-16EA - Each16729-0478309dc33-7ab2-4f21-b01d-ec2dae00361f12018-08-13

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 121 of 145 · 2,892 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Extra Strength Assorted Berry Antacid 127AB Extra strength Assorted Berry AntacidCALCIUM CARBONATEFamily Dollar Services, Inc.22aaa23b-a0a2-42cd-962a-1f76941cdac12024-04-17WarningsExact identifier
unii: H0G9379FGK
Family Wellness Extra Strength Smooth Antacid 173bfCALCIUM CARBONATEFamily Dollar Services, Inc.ee4aed8d-899e-4a27-9d95-b11151eec2982024-04-17WarningsExact identifier
unii: H0G9379FGK
FW Extra Strength AF Smooth AntacidCALCIUM CARBONATEFamily Dollar Services, Inc.e13981be-a13a-4ccd-85ce-0060db6232b22024-04-16WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites Assorted BerriesCALCIUM CARBONATENavajo Manufacturing Company Inc.1625c724-7ead-cc70-e063-6294a90aa5582024-04-15WarningsExact identifier
unii: H0G9379FGK
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDENavajo Manufacturing Company Incac3cd760-4615-117b-e053-2a95a90a8d422024-04-15WarningsExact identifier
unii: H0G9379FGK
LipitorATORVASTATIN CALCIUMViatris Specialty LLCa60cc18b-0631-4cf0-b021-9f52224ece652024-04-15Warnings, Adverse reactionsExact identifier
rxcui: 617311
rxcui: 617310
rxcui: 259255
rxcui: 617312
unii: 48A5M73Z4Q
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions1cc2dd41-a465-45b6-a80a-67c41af29cf82024-04-10Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions2ad89657-cc95-44a0-af6a-ee756526aa102024-04-10Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions103cc381-3266-409d-bdc2-1de620bae3552024-04-10Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionse52b4b11-9618-4787-ae67-44e4a3166dfb2024-04-10Warnings, Adverse reactionsExact identifier
rxcui: 259255
unii: 48A5M73Z4Q
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions0ec97c59-9d17-45f8-93f9-2c1f0361cb752024-04-10Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionse6d068ed-f9d2-4fd1-9755-b76bea89725e2024-04-10Warnings, Adverse reactionsExact identifier
rxcui: 617312
unii: 48A5M73Z4Q
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLC62fc0a91-c44f-4546-a472-c183a2d954862024-04-05WarningsExact identifier
unii: H0G9379FGK
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack5868d3c2-ae17-4a7e-9580-7c3cf9bf009e2024-04-05Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
TUMS CHEWY BITESCALCIUM CARBONATE TABLET, CHEWABLELil' Drug Store Products, Inc.f67bd767-e9f1-2377-e053-2a95a90a0a2d2024-03-29WarningsExact identifier
unii: H0G9379FGK
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
unii: 15FIX9V2JP
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
unii: 15FIX9V2JP
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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