Lovastatin

Product NDC: 70518-3064
Requested package NDC: 70518-3064-1
11-digit product format: 705183064
Labeler code: 70518
Product ID: 70518-3064_4e90ea05-c099-5658-e063-6394a90a1c44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075551
Marketing category: ANDA
Marketing start: 2021-04-02
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 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.

Product history page 1 of 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-003	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075551-001	LOVASTATIN	40MG	TABLET / ORAL	AB	2001-12-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075551-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075551-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075551-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075551-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075551-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075551-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075551-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075551-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075551-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075551-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075551-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075551-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075551-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075551-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075551-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075551-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075551-001	AB	1	`8072bd15b7f6…`

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
a902a95f-072a-4487-99a9-109a93f8b23c	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-3064-0	2023-03-15	Lovastatin Tablets, USP Rx only
70518-3064-1	2023-03-15	Lovastatin Tablets, USP Rx only
70518-3064-0	2023-01-30	Lovastatin Tablets, USP Rx only
70518-3064-1	2023-01-30	Lovastatin Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-3064-0	Lovastatin	90 in 1 BOTTLE, PLASTIC	TABLET	90		6
70518-3064-1	Lovastatin	30 in 1 BLISTER PACK	TABLET	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3064	LOVASTATIN TABLET [REMEDYREPACK INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240312_a902a95f-072a-4487-99a9-109a93f8b23c.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 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 ndc (package): 70518-3064-1 ndc (product): 70518-3064 ndc11 (package): 70518306401
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
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

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	a902a95f-072a-4487-99a9-109a93f8b23c	6
197905	lovastatin 40 MG Oral Tablet	SCD	a902a95f-072a-4487-99a9-109a93f8b23c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3064-1	70518306401	30 TABLET in 1 BLISTER PACK (70518-3064-1)	30 tablet	2021-05-12	0000-00-00	No	No	Current