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 83 of 145 · 2,892 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLCedb0f11a-bdb7-484d-9257-09ff47b0fca42025-07-15WarningsExact identifier
unii: H0G9379FGK
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
unii: 15FIX9V2JP
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
unii: 15FIX9V2JP
leader acid reducer completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECardinal Health 110, LLC. dba Leader6a492dd2-61f1-4020-bebd-fcc8e56472072025-07-08WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEKroger Companybf2fcb88-418f-4d5d-85ba-ec165a53ab042025-07-07WarningsExact identifier
unii: H0G9379FGK
MGC Health Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3958ec0a-8f32-6918-e063-6294a90ac1c42025-07-07WarningsExact identifier
unii: H0G9379FGK
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.395dbb88-5889-c91c-e063-6394a90a8daf2025-07-07Warnings, Adverse reactionsExact identifier
rxcui: 259255
unii: 48A5M73Z4Q
Equate Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWal-Mart Stores Inccb683c1c-db81-40a9-9ec5-f8dfa0dcf8122025-07-07WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEH E Bea712fc4-7f27-4556-b1b8-028f3f6ce57a2025-07-07WarningsExact identifier
unii: H0G9379FGK
DG Health acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEDolgencorp, LLC95c2c515-0f31-49d9-b799-7aaded81a37c2025-07-07WarningsExact identifier
unii: H0G9379FGK
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
unii: 15FIX9V2JP
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDETopco Associates LLC8ef70327-9a04-413b-b331-f5d3a94d6b362025-07-01WarningsExact identifier
unii: H0G9379FGK
KOSHER MEDS antacidCALCIUM CARBONATEMollec Inc7783d6a2-56e3-4542-ad1d-60680e03532b2025-07-01WarningsExact identifier
unii: H0G9379FGK
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEWalgreen Company3a456dab-0a2d-4e48-a8e2-e49a7acef9632025-07-01WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEH E Bc1aa7efa-4be1-4c8f-8994-661dd60e1aa92025-07-01WarningsExact identifier
unii: H0G9379FGK
leader acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECardinal Health 110, LLC. dba Leadera5420ef1-313f-4561-baf1-7ae017ea343a2025-07-01WarningsExact identifier
unii: H0G9379FGK
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepack9c58c4cd-fe1c-4db7-832c-874766e4da212025-06-25Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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