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 81 of 145 · 2,892 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
SUNSCREEN SPF50ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDEGuangzhou Tinsun Biotechnology Company Limited3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e2025-08-07WarningsExact identifier
unii: 15FIX9V2JP
AntacidCALCIUM CARBONATEProStat First Aid3bb49eb3-2eaa-af8d-e063-6294a90a40352025-08-06WarningsExact identifier
unii: H0G9379FGK
Dolce and Gabbana Everlast Foundation SPF 20 17W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L053cb3cd-dd16-4d08-b347-a4349fa37c072025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 14W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L7bf90657-b636-41d6-b96c-88d174989f5b2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 15N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lda7e19cd-6a8b-47df-bfc9-2f0f11b7955c2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 16N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf7a1d379-6de0-4be4-84a9-e0ebef332bef2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 18N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L671be8a6-51b7-45d2-9fff-c7736d2eea3e2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 19W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9efa5db5-d774-4089-895c-9667eda0f11b2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 20C MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L76232666-e23f-4842-bd0d-37819739ec3a2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 21W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L876b9a5d-dae3-47f1-9da6-b5e179fd28cd2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTSTITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC3bba70e9-da29-f43b-e063-6294a90a08ef2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0127f290-8c5e-4285-e063-6294a90ae1282025-08-06WarningsExact identifier
unii: 15FIX9V2JP
GR BB SPF 25OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI3b22579b-21ce-4b96-bd24-774ce35bf6f72025-08-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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