FDA.reportPublic FDA data

NDC 72205-005-11 - ROSUVASTATIN

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
72205-005
Requested NDC
72205-005-11
Package NDCs from labels
72205-005-30, 72205-005-90, 72205-005-99, 72205-005-11, 72205-005-06, 72205-005-05
Manufacturer
DIRECT RX
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
ROSUVASTATIN - DIRECT RXDIRECT RX2026-03-05HUMAN PRESCRIPTION DRUG LABEL
Rosuvastatin Calcium - Proficient Rx LPProficient Rx LP2024-12-01HUMAN PRESCRIPTION DRUG LABEL
Rosuvastatin CalciumNovadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc.2024-11-28Human Prescription Drug Label
Rosuvastatin Calcium - REMEDYREPACK INC.REMEDYREPACK INC.2024-02-27HUMAN PRESCRIPTION DRUG LABEL
Rosuvastatin Calcium - REMEDYREPACK INC.REMEDYREPACK INC.2024-02-27HUMAN PRESCRIPTION DRUG LABEL
Rosuvastatin Calcium - Bryant Ranch PrepackBryant Ranch Prepack2023-11-20HUMAN PRESCRIPTION DRUG LABEL
Rosuvastatin Calcium - A-S Medication SolutionsA-S Medication Solutions2023-08-31Human Prescription Drug Label
Rosuvastatin Calcium - A-S Medication SolutionsA-S Medication Solutions2023-08-31Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-005-05Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5009
72205-005-06Rosuvastatin Calcium100 in 1 CARTONTABLET, FILM COATED1009
72205-005-11Rosuvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED109
72205-005-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED309
72205-005-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
72205-005-99Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-005ROSUVASTATIN CALCIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 6 package rows20250302_d58f1f63-4bb6-413c-9730-ded3e8078618.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-005-30EA - Each72205-0051dd73169-0b52-4ed5-b73c-b63836f40c4212018-09-05
72205-005-90EA - Each72205-005536b11f0-33c6-4962-aaf3-6a5bd84c13f212018-10-11
72205-005-99EA - Each72205-0057290b378-f4de-417b-97db-0678fd20790a12018-09-05

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 14 of 112 · 2,228 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
unii: 15FIX9V2JP
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
unii: 15FIX9V2JP
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
unii: 15FIX9V2JP
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50TITANIUM DIOXIDE, ZINC OXIDESummer Friday's LLC4d3e982f-3489-dce2-e063-6294a90a1b9d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
HYDRATING TINTED MOISTURIZER SPF50HYDRATING TINTED MOISTURIZER SPF50NING PTE. LTD.4cf8d3d3-eebf-2da0-e063-6294a90a70652026-03-14WarningsExact identifier
unii: 15FIX9V2JP
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
ROSUVASTATINROSUVASTATINDIRECT RX99602058-4681-7cb5-e053-2995a90a099c2026-03-05Warnings, Adverse reactionsExact identifier
application number: ANDA208898
ndc (package): 72189-106-90
ndc (package): 72189-065-30
ndc (package): 72189-106-30
ndc (package): 72189-065-90
ndc (product): 72189-065
ndc (product): 72189-106
rxcui: 859424
rxcui: 859419
spl id: 4c499576-6f7a-6e58-e063-6294a90ab6a0
spl set id: 99602058-4681-7cb5-e053-2995a90a099c
unii: 83MVU38M7Q
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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