Rosuvastatin

Product NDC
55700-575
11-digit product format
557000575
Labeler code
55700
Product ID
55700-575_695e5654-9223-49aa-bfb2-4ff3370b0acf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA207616
Marketing category
ANDA
Marketing start
2018-01-05
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-575-30EA - Each55700-5759fdc5f30-b119-4bf7-9e2e-0e538527250512018-02-20
55700-575-90EA - Each55700-57526ffe19f-e30f-4740-8384-444c6350277412024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-575ROSUVASTATIN TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]9Legacy NDC20250101_616fd0c5-39c8-4276-9bcd-b045a08d08de.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-575-305570005753030 TABLET, FILM COATED in 1 BOTTLE (55700-575-30) 2018-01-050000-00-00NoNoCurrent