NDC 68084-558-11 - Lovastatin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68084-558
Requested NDC: 68084-558-11
Package NDCs from labels: 68084-558-11, 68084-558-01
Manufacturer: American Health Packaging
Effective date: 2019-03-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Lovastatin - American Health Packaging	American Health Packaging	2019-03-25	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-558-01	EA - Each	68084-558	6409c1c9-5011-4e96-937c-b14f86044c36	1	2012-07-24
68084-558-11	EA - Each	68084-558	d8c032bc-d178-46a2-b425-fb87d3d66b5b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [AMERICAN HEALTH PACKAGING]	5

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	Proficient Rx LP	f9e27117-db98-48bc-b7bc-fc98c9b719cf	2019-11-01	Warnings, Adverse reactions	Exact identifier unii: 9LHU78OQFD
84eebf5e-442d-4530-e053-2a91aa0a18ff			f65dbfca-bfb4-42ed-9b05-34769d81d04c	2019-03-25	Warnings, Adverse reactions	Exact identifier spl id: 84eebf5e-442d-4530-e053-2a91aa0a18ff spl set id: f65dbfca-bfb4-42ed-9b05-34769d81d04c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.