Lovastatin

Product NDC: 10544-246
11-digit product format: 105440246
Labeler code: 10544
Product ID: 10544-246_531d78b5-f3ba-4430-b6ad-85cabeb7d058
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA075828
Marketing category: ANDA
Marketing start: 2010-06-22
Marketing end: 0000-00-00
Substance: LOVASTATIN
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
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508
f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5	Product name	1	20140508
fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-246-30	2020-01-31	C162847	48780-1	9d75b9d1-2a63-f424-e053-dadaa90a57ce	LOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-246-30	Lovastatin	30 in 1 BOTTLE	TABLET	30		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-246-30	EA - Each	10544-246	48fedad1-4588-4b81-b5b7-56ce63d85017	1	2015-11-12

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-246	LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]	2	Legacy NDC, 1 package rows	20151022_f0251754-a956-4e62-94b7-e4dd15445f8c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9LHU78OQFD	LOVASTATIN	75330-75-5	LOVASTATIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197904	lovastatin 20 MG Oral Tablet	PSN	f0251754-a956-4e62-94b7-e4dd15445f8c	2
197904	lovastatin 20 MG Oral Tablet	SCD	f0251754-a956-4e62-94b7-e4dd15445f8c	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-246-30	10544024630	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only	Blenheim Pharmacal, Inc.	2015-10-02	Human Prescription Drug Label	2