Lovastatin

Product NDC: 68788-8232
Requested package NDC: 68788-8232-3
11-digit product format: 687888232
Labeler code: 68788
Product ID: 68788-8232_19500b45-4a52-42a9-b3a5-36d634d4dd61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA078296
Marketing category: ANDA
Marketing start: 2022-08-08
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
A078296-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14
A078296-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01
A078296-003	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078296-001	AB
A078296-002	AB
A078296-003	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	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`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	A078296-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078296-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078296-003	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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	e75b5808-ec66-4da7-90bc-e53611aa1b34	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	397949f9-ce60-424f-9902-90e65a34f4de	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296 ndc (package): 68788-8232-3 ndc (product): 68788-8232 ndc11 (package): 68788823203
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	22c9f2d8-7bcd-4415-bbc8-505720033966	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	030c0f79-6bb5-4876-bf8e-b7a25b25dd38	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	f5f265a6-2aa5-4205-9159-40133ae93ac0	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	BluePoint Laboratories	7b86160d-74a9-4774-b5b3-5641e686991f	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	ff040b3c-6790-40d7-bd64-a4073b4a2045	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Lupin Pharmaceuticals, Inc.	df7ddf4f-d569-431e-81f1-9129d7043150	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Legacy Pharmaceutical Packaging, LLC	a4f02fa1-3281-46fa-bd52-323e2644b6f8	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	f308fe1c-23a9-6409-e053-2995a90abfd9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	ca59cbd4-a4c1-aebe-e053-2a95a90ae968	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	f99e0b4c-e757-4ccd-e053-6294a90ab722	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	A-S Medication Solutions	06b8c398-ce2e-42c1-b1a8-73cc59a080db	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2eeb34ac-f973-e7d9-e063-6294a90a076e	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	50217921-97a7-6ff2-e054-00144ff88e88	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	A-S Medication Solutions	02aae38d-ee9d-4c09-a155-b69f221ed3e9	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	3af47e72-082d-42ad-bde0-294f8101b45c	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals,Inc.	19b2bb87-1dc7-cd72-e063-6394a90a0f73	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals,Inc.	1ac7ffb9-860a-fbb6-e063-6294a90a590f	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296
Lovastatin	LOVASTATIN	Proficient Rx LP	2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078296 application number: ANDA078296

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
397949f9-ce60-424f-9902-90e65a34f4de	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
68788-8232-3	Lovastatin	30 in 1 BOTTLE	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8232-3	EA - Each	68788-8232	5defc608-4413-4016-b18f-f116d115a82e	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8232	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240704_397949f9-ce60-424f-9902-90e65a34f4de.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
197905	lovastatin 40 MG Oral Tablet	PSN	397949f9-ce60-424f-9902-90e65a34f4de	4
197905	lovastatin 40 MG Oral Tablet	SCD	397949f9-ce60-424f-9902-90e65a34f4de	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8232-3	68788823203	30 TABLET in 1 BOTTLE (68788-8232-3)	30 tablet	2022-08-08	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	5