ATORVASTATIN CALCIUM

Product NDC: 42254-019
11-digit product format: 422540019
Labeler code: 42254
Product ID: 42254-019_2a8de5aa-936a-493e-a0e3-813cbc969c6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020702
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1996-12-17
Marketing end: 0000-00-00
Substance: ATORVASTATIN CALCIUM
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
d25cba4b-d79e-4890-8837-1382f7d09489	Product name	1	20231002
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1c	Product name	1	20220302
34152997-af0b-acf4-dcaf-37211afe8ca4	Product name	9	20210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-019-90	2019-09-24	C162847	48780-1	9350213a-3d07-c013-e053-90daa90a1393	These highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-019-90	ATORVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-019-90	EA - Each	42254-019	55da8103-6df1-445a-b57a-0106585b43b5	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ATORVASTATIN CALCIUM	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-019	ATORVASTATIN CALCIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20111229_2a8de5aa-936a-493e-a0e3-813cbc969c6d.zip

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	2a8de5aa-936a-493e-a0e3-813cbc969c6d	1
617311	atorvastatin 40 MG Oral Tablet	SCD	2a8de5aa-936a-493e-a0e3-813cbc969c6d	1
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	2a8de5aa-936a-493e-a0e3-813cbc969c6d	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-019-90	42254001990	90 in 1 BOTTLE	Historical