ATORVALIQ

Product NDC
46287-030
11-digit product format
462870030
Labeler code
46287
Product ID
46287-030_fb92775a-6d6d-4d62-ab23-045f16ec5895
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVALIQ
Dosage form
SUSPENSION
Route
ORAL
Labeler
CMP Pharma, Inc.
Application
NDA213260
Marketing category
NDA
Marketing start
2023-03-01
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 mg/5mL
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ATORVALIQ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE20 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui2630760

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46287-030-01ATORVALIQ150 mL in 1 BOTTLESuspension1503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46287-030-01ML - Milliliter46287-0309a27be70-35b8-477b-88db-768e79c562c412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46287-030ATORVALIQ SUSPENSION [CMP PHARMA, INC.]3Current NDC, 1 package rows20240823_41fca2d8-7f3f-45b9-8974-81b89accc211.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2630760atorvastatin calcium 20 MG in 5 mL Oral SuspensionPSN41fca2d8-7f3f-45b9-8974-81b89accc2113
2630760atorvastatin 4 MG/ML Oral SuspensionSCD41fca2d8-7f3f-45b9-8974-81b89accc2113
2630760atorvastatin (as atorvastatin calcium) 20 MG per 5 ML Oral SuspensionSY41fca2d8-7f3f-45b9-8974-81b89accc2113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46287-030-0146287003001150 mL in 1 BOTTLE (46287-030-01) 150 ml2023-03-01NoNoHistorical