Lovastatin

Product NDC: 0093-0928
11-digit product format: 000930928
Labeler code: 0093
Product ID: 0093-0928_caf8172a-311b-447a-8c8b-e9d70c23c8e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075551
Marketing category: ANDA
Marketing start: 2001-12-17
Substance: LOVASTATIN
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075551-001	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17
A075551-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17
A075551-003	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075551-001	AB
A075551-002	AB
A075551-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075551-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075551-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075551-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	a902a95f-072a-4487-99a9-109a93f8b23c	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	Golden State Medical Supply, Inc.	91332c54-1a27-4e6b-e053-2a95a90a42cd	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	A-S Medication Solutions	4ff981e8-5c86-4b86-baa1-825551905ed8	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	7e96b174-3887-4908-9b9f-5ef93540f96a	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551
Lovastatin	LOVASTATIN	Teva Pharmaceuticals USA, Inc.	0e15feec-d27e-4861-8152-c5a8b8ccacd4	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551 ndc (product): 0093-0928
Lovastatin	LOVASTATIN	Proficient Rx LP	027bd594-6a0a-4e6d-bd3c-4f33fdb4166a	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075551 application number: ANDA075551

Additional Listing Data#

Finished product: Yes
Brand name base: Lovastatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOVASTATIN	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9LHU78OQFD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197903	Internal RxNorm lookup
197904	Internal RxNorm lookup
197905	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0e15feec-d27e-4861-8152-c5a8b8ccacd4	Available on FDA.report

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	Strength	SPL version
0093-0928-06	Lovastatin	60 in 1 BOTTLE	TABLET	60		21
0093-0928-10	Lovastatin	1000 in 1 BOTTLE	TABLET	1000		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0928-06	EA - Each	0093-0928	d8e4e6c2-99c7-4695-b123-a83080615dd6	1	2012-07-24
0093-0928-10	EA - Each	0093-0928	285bb6b7-9cdf-4218-b7a9-683df5a2277f	1	2012-07-24
0093-0928-19	EA - Each	0093-0928	7180951f-48c1-4818-b2f9-c6ed6d434019	1	2012-07-24
0093-0928-93	EA - Each	0093-0928	fb0d673a-2c8b-4a05-af59-3f5e14b53efe	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA INC]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0928	LOVASTATIN TABLET [TEVA PHARMACEUTICALS USA, INC.]	21	Current NDC, Legacy NDC, 2 package rows	20250227_0e15feec-d27e-4861-8152-c5a8b8ccacd4.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	0e15feec-d27e-4861-8152-c5a8b8ccacd4	21
197904	lovastatin 20 MG Oral Tablet	PSN	0e15feec-d27e-4861-8152-c5a8b8ccacd4	21
197905	lovastatin 40 MG Oral Tablet	PSN	0e15feec-d27e-4861-8152-c5a8b8ccacd4	21
197903	lovastatin 10 MG Oral Tablet	SCD	0e15feec-d27e-4861-8152-c5a8b8ccacd4	21
197904	lovastatin 20 MG Oral Tablet	SCD	0e15feec-d27e-4861-8152-c5a8b8ccacd4	21
197905	lovastatin 40 MG Oral Tablet	SCD	0e15feec-d27e-4861-8152-c5a8b8ccacd4	21
197903	lovastatin 10 MG Oral Tablet	PSN	4ff981e8-5c86-4b86-baa1-825551905ed8	8
197905	lovastatin 40 MG Oral Tablet	PSN	4ff981e8-5c86-4b86-baa1-825551905ed8	8
197903	lovastatin 10 MG Oral Tablet	SCD	4ff981e8-5c86-4b86-baa1-825551905ed8	8
197905	lovastatin 40 MG Oral Tablet	SCD	4ff981e8-5c86-4b86-baa1-825551905ed8	8
197903	lovastatin 10 MG Oral Tablet	PSN	91332c54-1a27-4e6b-e053-2a95a90a42cd	6
197904	lovastatin 20 MG Oral Tablet	PSN	91332c54-1a27-4e6b-e053-2a95a90a42cd	6
197905	lovastatin 40 MG Oral Tablet	PSN	91332c54-1a27-4e6b-e053-2a95a90a42cd	6
197905	lovastatin 40 MG Oral Tablet	PSN	a902a95f-072a-4487-99a9-109a93f8b23c	6
197903	lovastatin 10 MG Oral Tablet	SCD	91332c54-1a27-4e6b-e053-2a95a90a42cd	6
197904	lovastatin 20 MG Oral Tablet	SCD	91332c54-1a27-4e6b-e053-2a95a90a42cd	6
197905	lovastatin 40 MG Oral Tablet	SCD	91332c54-1a27-4e6b-e053-2a95a90a42cd	6
197905	lovastatin 40 MG Oral Tablet	SCD	a902a95f-072a-4487-99a9-109a93f8b23c	6
197905	lovastatin 40 MG Oral Tablet	PSN	d9e29a11-c0a7-c5a0-e053-2a95a90a5831	1
197905	lovastatin 40 MG Oral Tablet	SCD	d9e29a11-c0a7-c5a0-e053-2a95a90a5831	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0928-06	00093092806	60 TABLET in 1 BOTTLE (0093-0928-06)	60 tablet	2001-12-17	0000-00-00	No	No	Current
0093-0928-10	00093092810	1000 TABLET in 1 BOTTLE (0093-0928-10)	1000 tablet	2001-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lovastatin Tablets, USP Rx only	REMEDYREPACK INC.	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	6
Lovastatin Tablets, USP Rx only	Golden State Medical Supply, Inc.	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	6
Lovastatin Tablets, USP Rx only	A-S Medication Solutions	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	8
Lovastatin Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2022-03-10	HUMAN PRESCRIPTION DRUG LABEL	1
Lovastatin Tablets, USP Rx only	Teva Pharmaceuticals USA, Inc.	2020-08-01	HUMAN PRESCRIPTION DRUG LABEL	21