Lovastatin

Product NDC: 68645-567
11-digit product format: 686450567
Labeler code: 68645
Product ID: 68645-567_4cc241a1-d876-0439-e063-6394a90a2733
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Legacy Pharmaceutical Packaging, LLC
Application: ANDA078296
Marketing category: ANDA
Marketing start: 2007-11-01
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 4 · 126 observed 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
2026-08-18 06:07:40	2026-07	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078296-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2007-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078296-003	LOVASTATIN	40MG	TABLET / ORAL	AB	2007-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078296-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2008-03-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078296-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078296-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078296-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078296-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078296-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078296-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078296-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078296-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078296-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078296-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078296-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078296-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078296-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078296-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078296-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078296-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078296-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078296-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078296-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078296-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078296-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078296-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078296-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078296-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
a4f02fa1-3281-46fa-bd52-323e2644b6f8	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
68645-567-90	Lovastatin	90 in 1 BOTTLE	TABLET	90		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68645-567-90	EA - Each	68645-567	84317a03-7f23-4222-9ae3-15f2793496e6	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68645-567	LOVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC]	8	Current NDC, Legacy NDC, 1 package rows	20250418_a4f02fa1-3281-46fa-bd52-323e2644b6f8.zip

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 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
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 ndc (product): 68645-567
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

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68645-567-90	68645056790	90 TABLET in 1 BOTTLE (68645-567-90)	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	Legacy Pharmaceutical Packaging, LLC	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	9