FDA.reportPublic FDA data

Rosuvastatin

Product NDC
31722-883
11-digit product format
317220883
Labeler code
31722
Product ID
31722-883_49d450b0-95af-a362-e063-6294a90a3e99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA207616
Marketing category
ANDA
Marketing start
2016-10-29
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859419, 859424, 859747, 859751

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-883-31Rosuvastatin100 in 1 CARTONTABLET, FILM COATED1006
31722-883-90Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-883-90EA - Each31722-8837355b091-e96a-4624-837e-be3d51dcfeb512016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-883ROSUVASTATIN (ROSUVASTATIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20250213_7778df5a-82c1-4a86-8867-a3325da025ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN7778df5a-82c1-4a86-8867-a3325da025ec6
859751rosuvastatin calcium 20 MG Oral TabletPSN7778df5a-82c1-4a86-8867-a3325da025ec6
859419rosuvastatin calcium 40 MG Oral TabletPSN7778df5a-82c1-4a86-8867-a3325da025ec6
859424rosuvastatin calcium 5 MG Oral TabletPSN7778df5a-82c1-4a86-8867-a3325da025ec6
859747rosuvastatin calcium 10 MG Oral TabletSCD7778df5a-82c1-4a86-8867-a3325da025ec6
859751rosuvastatin calcium 20 MG Oral TabletSCD7778df5a-82c1-4a86-8867-a3325da025ec6
859419rosuvastatin calcium 40 MG Oral TabletSCD7778df5a-82c1-4a86-8867-a3325da025ec6
859424rosuvastatin calcium 5 MG Oral TabletSCD7778df5a-82c1-4a86-8867-a3325da025ec6
859747rosuvastatin calcium 10 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859751rosuvastatin calcium 20 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859419rosuvastatin calcium 40 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859747rosuvastatin calcium 10 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859751rosuvastatin calcium 20 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859419rosuvastatin calcium 40 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859747rosuvastatin calcium 10 MG Oral TabletPSNb85227e5-1838-7591-e053-2a95a90ace491
859747rosuvastatin calcium 10 MG Oral TabletSCDb85227e5-1838-7591-e053-2a95a90ace491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-883-3131722088331100 TABLET, FILM COATED in 1 CARTON (31722-883-31) 2016-10-290000-00-00NoNoCurrent
31722-883-903172208839090 TABLET, FILM COATED in 1 BOTTLE (31722-883-90) 2016-10-290000-00-00NoNoCurrent