Simvastatin

Product NDC: 10544-486
11-digit product format: 105440486
Labeler code: 10544
Product ID: 10544-486_46615c70-6322-4bcb-a8bb-c76e79f8bcff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA077837
Marketing category: ANDA
Marketing start: 2014-02-10
Marketing end: 0000-00-00
Substance: SIMVASTATIN
Active strength: 20 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
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-486-30	2020-01-31	C162847	48780-1	9d75b9d0-acc3-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin. SIMVASTATIN tablets USP, for oral use. Initial U.S. Approval: 1991

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-486-30	Simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-486-30	EA - Each	10544-486	c6e58a63-f3ae-4459-b8b0-9ca9e4a12e4a	1	2016-01-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-486	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 1 package rows	20151230_4fd79a00-7215-4fb5-8284-688687d99bef.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312961	simvastatin 20 MG Oral Tablet	PSN	4fd79a00-7215-4fb5-8284-688687d99bef	1
198211	simvastatin 40 MG Oral Tablet	PSN	4fd79a00-7215-4fb5-8284-688687d99bef	1
312961	simvastatin 20 MG Oral Tablet	SCD	4fd79a00-7215-4fb5-8284-688687d99bef	1
198211	simvastatin 40 MG Oral Tablet	SCD	4fd79a00-7215-4fb5-8284-688687d99bef	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-486-30	10544048630	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Simvastatin	Blenheim Pharmacal, Inc. \| Blenheim Pharacal, Inc.	2015-12-30	HUMAN PRESCRIPTION DRUG LABEL	1