Lovastatin

Product NDC: 68180-468
11-digit product format: 681800468
Labeler code: 68180
Product ID: 68180-468_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: 2007-11-01
Substance: LOVASTATIN
Active strength: 20 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	20 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
68180-468-01	Lovastatin	100 in 1 BOTTLE	TABLET	100	17
68180-468-03	Lovastatin	1000 in 1 BOTTLE	TABLET	1000	17
68180-468-05	Lovastatin	5000 in 1 BOTTLE	TABLET	5000	17
68180-468-07	Lovastatin	60 in 1 BOTTLE	TABLET	60	17
68180-468-09	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
68180-468-01	EA - Each	68180-468	17c6ef3a-e44c-4f8b-84a8-3a4c97ccb021	1	2012-07-24
68180-468-03	EA - Each	68180-468	de812a70-7db6-4df4-a798-8c7a0ecf5406	1	2012-07-24
68180-468-05	EA - Each	68180-468	1b85b98a-32b2-4824-b351-62e67d4c0bed	1	2012-07-24
68180-468-07	EA - Each	68180-468	ddb25a2a-3c2d-4258-9877-2ac81ac74cc4	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-468	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
197904	lovastatin 20 MG Oral Tablet	PSN	02aae38d-ee9d-4c09-a155-b69f221ed3e9	18
197905	lovastatin 40 MG Oral Tablet	PSN	02aae38d-ee9d-4c09-a155-b69f221ed3e9	18
197904	lovastatin 20 MG Oral Tablet	SCD	02aae38d-ee9d-4c09-a155-b69f221ed3e9	18
197905	lovastatin 40 MG Oral Tablet	SCD	02aae38d-ee9d-4c09-a155-b69f221ed3e9	18
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
197904	lovastatin 20 MG Oral Tablet	PSN	3af47e72-082d-42ad-bde0-294f8101b45c	15
197905	lovastatin 40 MG Oral Tablet	PSN	3af47e72-082d-42ad-bde0-294f8101b45c	15
197904	lovastatin 20 MG Oral Tablet	SCD	3af47e72-082d-42ad-bde0-294f8101b45c	15
197905	lovastatin 40 MG Oral Tablet	SCD	3af47e72-082d-42ad-bde0-294f8101b45c	15
197904	lovastatin 20 MG Oral Tablet	PSN	ff040b3c-6790-40d7-bd64-a4073b4a2045	13
197904	lovastatin 20 MG Oral Tablet	SCD	ff040b3c-6790-40d7-bd64-a4073b4a2045	13
197904	lovastatin 20 MG Oral Tablet	PSN	a4f02fa1-3281-46fa-bd52-323e2644b6f8	9
197905	lovastatin 40 MG Oral Tablet	PSN	a4f02fa1-3281-46fa-bd52-323e2644b6f8	9
197904	lovastatin 20 MG Oral Tablet	SCD	a4f02fa1-3281-46fa-bd52-323e2644b6f8	9
197905	lovastatin 40 MG Oral Tablet	SCD	a4f02fa1-3281-46fa-bd52-323e2644b6f8	9
197904	lovastatin 20 MG Oral Tablet	PSN	555135d6-53b1-4575-93ed-3eb73f7b3160	8
197904	lovastatin 20 MG Oral Tablet	PSN	f5f265a6-2aa5-4205-9159-40133ae93ac0	8
197904	lovastatin 20 MG Oral Tablet	SCD	555135d6-53b1-4575-93ed-3eb73f7b3160	8
197904	lovastatin 20 MG Oral Tablet	SCD	f5f265a6-2aa5-4205-9159-40133ae93ac0	8
197904	lovastatin 20 MG Oral Tablet	PSN	50217921-97a7-6ff2-e054-00144ff88e88	6
197904	lovastatin 20 MG Oral Tablet	SCD	50217921-97a7-6ff2-e054-00144ff88e88	6
197904	lovastatin 20 MG Oral Tablet	PSN	2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb	5
197904	lovastatin 20 MG Oral Tablet	SCD	2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb	5
197904	lovastatin 20 MG Oral Tablet	PSN	22c9f2d8-7bcd-4415-bbc8-505720033966	3
197904	lovastatin 20 MG Oral Tablet	PSN	ca59cbd4-a4c1-aebe-e053-2a95a90ae968	3
197904	lovastatin 20 MG Oral Tablet	SCD	ca59cbd4-a4c1-aebe-e053-2a95a90ae968	3
197904	lovastatin 20 MG Oral Tablet	SCD	22c9f2d8-7bcd-4415-bbc8-505720033966	3
197904	lovastatin 20 MG Oral Tablet	PSN	19b2bb87-1dc7-cd72-e063-6394a90a0f73	2
197904	lovastatin 20 MG Oral Tablet	SCD	19b2bb87-1dc7-cd72-e063-6394a90a0f73	2
197903	lovastatin 10 MG Oral Tablet	PSN	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197903	lovastatin 10 MG Oral Tablet	PSN	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197904	lovastatin 20 MG Oral Tablet	PSN	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197904	lovastatin 20 MG Oral Tablet	PSN	2eeb34ac-f973-e7d9-e063-6294a90a076e	1
197904	lovastatin 20 MG Oral Tablet	PSN	347c802f-4ea9-41d4-80d6-e4a183f22179	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	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197903	lovastatin 10 MG Oral Tablet	SCD	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197904	lovastatin 20 MG Oral Tablet	SCD	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197904	lovastatin 20 MG Oral Tablet	SCD	2eeb34ac-f973-e7d9-e063-6294a90a076e	1
197904	lovastatin 20 MG Oral Tablet	SCD	347c802f-4ea9-41d4-80d6-e4a183f22179	1
197905	lovastatin 40 MG Oral Tablet	SCD	8d2199d5-80bd-497f-8c74-f3e613b9800d	1
197905	lovastatin 40 MG Oral Tablet	SCD	347c802f-4ea9-41d4-80d6-e4a183f22179	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-468-01	68180046801	100 TABLET in 1 BOTTLE (68180-468-01)	100 tablet	2007-11-01	0000-00-00	No	No	Current
68180-468-03	68180046803	1000 TABLET in 1 BOTTLE (68180-468-03)	1000 tablet	2007-11-01	0000-00-00	No	No	Current
68180-468-05	68180046805	5000 TABLET in 1 BOTTLE (68180-468-05)	5000 tablet	2007-11-01	0000-00-00	No	No	Current
68180-468-07	68180046807	60 TABLET in 1 BOTTLE (68180-468-07)	60 tablet	2007-11-01	0000-00-00	No	No	Current
68180-468-09	68180046809	90 TABLET in 1 BOTTLE (68180-468-09)	90 tablet	2007-11-01	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	Preferred Pharmaceuticals, Inc.	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	4
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Bryant Ranch Prepack	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	8
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	REMEDYREPACK INC.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	13
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	Legacy Pharmaceutical Packaging, LLC	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	9
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Lovastatin 20mg Tablets	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2025-02-24	HUMAN PRESCRIPTION DRUG LABEL	1
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	NuCare Pharmaceuticals, Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	6
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	A-S Medication Solutions	2024-10-15	HUMAN PRESCRIPTION DRUG LABEL	18
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	15
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	2
LOVASTATIN TABLETS USP 20 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2024-03-13	HUMAN PRESCRIPTION DRUG LABEL	15
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only	RPK Pharmaceuticals, Inc.	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	8
LOVASTATIN TABLETS USP 20 mg Rx only	Proficient Rx LP	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL	5
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 TABLETS USP 10 mg, 20 mg and 40 mg Rx only	Rebel Distributors Corp	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#