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 140 of 145 · 2,895 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LP1923c91e-c6dd-4446-aabd-70a0c6aa1a822022-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA207687
rxcui: 617310
unii: 48A5M73Z4Q
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLC2b7fbe2a-1f7a-4944-b589-87ca05af74812022-03-02Warnings, Adverse reactionsExact identifier
rxcui: 259255
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDPatrin Pharma, Inc.59c5c1a4-3f42-441a-b842-903f9bab346f2022-01-13Boxed warningExact identifier
unii: H0G9379FGK
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS97e7ece8-a705-4988-ba52-6d3f115735212021-12-01WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 ChestnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS6a44f926-11b4-4bc4-8d5d-721a89c4f0cc2021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HazelnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASb58af664-b0fd-4585-8417-7c20954d7aff2021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 UmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS7bbd1334-fae8-4274-b927-a099af7643452021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 CedarOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS970571f9-3d6b-46ae-a668-745de1911fa22021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 WheatOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS542e1b2e-f63c-466b-b5ac-6c147a0e9dec2021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS21b65c12-6f67-4053-9508-6b2709cc1fb82021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS8ea4c470-ebd5-448e-b72a-ccd1113de0ab2021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HoneyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASfd9689a4-21d1-49f0-bf59-b8e1da72cd162021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 DuneOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc23b6a87-8cf9-4be3-8306-2285e7e926c12021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASa93cb6c6-d7c2-43cc-a2e8-961f896a977e2021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 LatteOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS32d99955-1593-426b-958e-5dcf689192a32021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 TawnyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS762deb57-754b-46a9-9907-de05e11da1782021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 AmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS3b5366e4-180a-4b98-9524-63601ae9d2702021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool VanillaOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e2021-11-04WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 CalicoOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS3e67abb5-84a4-4a78-9ea3-9fd57cbeb4822021-11-04WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS477d79c1-f169-4d0e-a95d-f5e832855f0d2021-11-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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