Lovastatin

Product NDC: 68180-467
11-digit product format: 681800467
Labeler code: 68180
Product ID: 68180-467_ebd1b7a8-bc2e-4f09-99b0-1e46a971d4f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA078296
Marketing category: ANDA
Marketing start: 2008-03-14
Substance: LOVASTATIN
Active strength: 10 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Lovastatin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOVASTATIN	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	9LHU78OQFD
Rxcui	197903, 197904, 197905

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68180-467-01	Lovastatin	100 in 1 BOTTLE	TABLET	100	17
68180-467-03	Lovastatin	1000 in 1 BOTTLE	TABLET	1000	17
68180-467-05	Lovastatin	5000 in 1 BOTTLE	TABLET	5000	17
68180-467-07	Lovastatin	60 in 1 BOTTLE	TABLET	60	17
68180-467-09	Lovastatin	90 in 1 BOTTLE	TABLET	90	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-467-01	EA - Each	68180-467	46a807ac-6be3-4f1c-b846-64ef98cf3fc6	1	2012-07-24
68180-467-03	EA - Each	68180-467	21e879bc-a275-4a04-a325-44acec88c1e7	1	2012-07-24
68180-467-07	EA - Each	68180-467	d031eee1-9c98-4af6-88b8-176ba5fbe255	1	2012-07-24
68180-467-09	EA - Each	68180-467	9bc8bd10-7e8d-45ea-8761-f39339ad8722	1	2020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	7
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	5
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [DIRECT RX]	2
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [DIRECT RX]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOVASTATIN TABLET [DIRECT RX]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [DIRECT RX]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [DIRECT RX]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOVASTATIN TABLET [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [DIRECT RX]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [DIRECT RX]	2
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [STAT RX USA LLC]	1
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOVASTATIN TABLET [STAT RX USA LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOVASTATIN TABLET [STAT RX USA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-467	LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]	14	Current NDC, Legacy NDC, 5 package rows	20231102_df7ddf4f-d569-431e-81f1-9129d7043150.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197903	lovastatin 10 MG Oral Tablet	PSN	df7ddf4f-d569-431e-81f1-9129d7043150	17
197904	lovastatin 20 MG Oral Tablet	PSN	df7ddf4f-d569-431e-81f1-9129d7043150	17
197905	lovastatin 40 MG Oral Tablet	PSN	df7ddf4f-d569-431e-81f1-9129d7043150	17
197903	lovastatin 10 MG Oral Tablet	SCD	df7ddf4f-d569-431e-81f1-9129d7043150	17
197904	lovastatin 20 MG Oral Tablet	SCD	df7ddf4f-d569-431e-81f1-9129d7043150	17
197905	lovastatin 40 MG Oral Tablet	SCD	df7ddf4f-d569-431e-81f1-9129d7043150	17
197903	lovastatin 10 MG Oral Tablet	PSN	06b8c398-ce2e-42c1-b1a8-73cc59a080db	10
197903	lovastatin 10 MG Oral Tablet	SCD	06b8c398-ce2e-42c1-b1a8-73cc59a080db	10
197903	lovastatin 10 MG Oral Tablet	PSN	e16b6922-8ebc-4ee6-b70e-31834e61a540	7
197903	lovastatin 10 MG Oral Tablet	SCD	e16b6922-8ebc-4ee6-b70e-31834e61a540	7
197903	lovastatin 10 MG Oral Tablet	PSN	f99e0b4c-e757-4ccd-e053-6294a90ab722	6
197903	lovastatin 10 MG Oral Tablet	SCD	f99e0b4c-e757-4ccd-e053-6294a90ab722	6
197903	lovastatin 10 MG Oral Tablet	PSN	0d3d6373-e3e9-456b-99eb-fbfe86a9ac32	5
197903	lovastatin 10 MG Oral Tablet	SCD	0d3d6373-e3e9-456b-99eb-fbfe86a9ac32	5
197903	lovastatin 10 MG Oral Tablet	PSN	8a77e539-a31e-43a4-a53e-a4204aa38558	4
197903	lovastatin 10 MG Oral Tablet	SCD	8a77e539-a31e-43a4-a53e-a4204aa38558	4
197903	lovastatin 10 MG Oral Tablet	PSN	f9e27117-db98-48bc-b7bc-fc98c9b719cf	3
197903	lovastatin 10 MG Oral Tablet	SCD	f9e27117-db98-48bc-b7bc-fc98c9b719cf	3
197903	lovastatin 10 MG Oral Tablet	PSN	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197903	lovastatin 10 MG Oral Tablet	PSN	1ac7ffb9-860a-fbb6-e063-6294a90a590f	1
197903	lovastatin 10 MG Oral Tablet	PSN	f208f4a4-cb3f-40bd-9873-bba0c8ae8bd4	1
197903	lovastatin 10 MG Oral Tablet	PSN	572983e6-c7a2-4b4d-a700-fcc5bdc444b6	1
197903	lovastatin 10 MG Oral Tablet	PSN	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197904	lovastatin 20 MG Oral Tablet	PSN	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197904	lovastatin 20 MG Oral Tablet	PSN	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197905	lovastatin 40 MG Oral Tablet	PSN	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197905	lovastatin 40 MG Oral Tablet	PSN	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197903	lovastatin 10 MG Oral Tablet	SCD	572983e6-c7a2-4b4d-a700-fcc5bdc444b6	1
197903	lovastatin 10 MG Oral Tablet	SCD	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197903	lovastatin 10 MG Oral Tablet	SCD	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197903	lovastatin 10 MG Oral Tablet	SCD	f208f4a4-cb3f-40bd-9873-bba0c8ae8bd4	1
197903	lovastatin 10 MG Oral Tablet	SCD	1ac7ffb9-860a-fbb6-e063-6294a90a590f	1
197904	lovastatin 20 MG Oral Tablet	SCD	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197904	lovastatin 20 MG Oral Tablet	SCD	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197905	lovastatin 40 MG Oral Tablet	SCD	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197905	lovastatin 40 MG Oral Tablet	SCD	8d2199d5-80bd-497f-8c74-f3e613b9800d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-467-01	68180046701	100 TABLET in 1 BOTTLE (68180-467-01)	100 tablet	2008-03-14	0000-00-00	No	No	Current
68180-467-03	68180046703	1000 TABLET in 1 BOTTLE (68180-467-03)	1000 tablet	2008-03-14	0000-00-00	No	No	Current
68180-467-05	68180046705	5000 TABLET in 1 BOTTLE (68180-467-05)	5000 tablet	2008-03-14	0000-00-00	No	No	Current
68180-467-07	68180046707	60 TABLET in 1 BOTTLE (68180-467-07)	60 tablet	2008-03-14	0000-00-00	No	No	Current
68180-467-09	68180046709	90 TABLET in 1 BOTTLE (68180-467-09)	90 tablet	2019-06-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	17
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	6
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	A-S Medication Solutions	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	10
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Preferred Pharmaceuticals, Inc.	2025-08-04	HUMAN PRESCRIPTION DRUG LABEL	4
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	NuCare Pharmaceuticals,Inc.	2024-06-13	HUMAN PRESCRIPTION DRUG LABEL	1
LOVASTATIN TABLETS USP 10 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2024-05-07	HUMAN PRESCRIPTION DRUG LABEL	16
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
LOVASTATIN	Direct Rx	2023-04-18	HUMAN PRESCRIPTION DRUG LABEL	7
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Aidarex Pharmaceuticals LLC	2017-05-25	HUMAN PRESCRIPTION DRUG LABEL	1
LOVASTATIN TABLETS USP 10 mg Rx only	STAT Rx USA LLC \| PSS World Medical Inc.	2012-09-27	HUMAN PRESCRIPTION DRUG LABEL	1
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Rebel Distributors Corp	2011-01-03	HUMAN PRESCRIPTION DRUG LABEL	1
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Physicians Total Care, Inc.	2011-01-03	HUMAN PRESCRIPTION DRUG LABEL	1

Lovastatin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#