Lovastatin

Product NDC: 43063-548
11-digit product format: 430630548
Labeler code: 43063
Product ID: 43063-548_2f3a8f82-8530-3a64-e063-6294a90aa0b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA075991
Marketing category: ANDA
Marketing start: 2002-11-25
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 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	RLD / RS	Approval date
A075991-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05
A075991-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05
A075991-003	LOVASTATIN	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075991-001	AB
A075991-002	AB
A075991-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-002	LOVASTATIN	20MG	TABLET / ORAL	AB		2002-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-003	LOVASTATIN	40MG	TABLET / ORAL	AB	RS	2002-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075991-001	LOVASTATIN	10MG	TABLET / ORAL	AB		2002-06-05	`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	A075991-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075991-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075991-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075991-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075991-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075991-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075991-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075991-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075991-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075991-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075991-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075991-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075991-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075991-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075991-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075991-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075991-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075991-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075991-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075991-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075991-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075991-001	AB	1	`1e350fbaab3a…`

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 · 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
eea93a4b-f804-4b9c-aabf-e906f03c1e80	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
43063-548-14	Lovastatin	14 in 1 BOTTLE, PLASTIC	TABLET	14	26
43063-548-30	Lovastatin	30 in 1 BOTTLE, PLASTIC	TABLET	30	26
43063-548-90	Lovastatin	90 in 1 BOTTLE, PLASTIC	TABLET	90	26
43063-548-93	Lovastatin	180 in 1 BOTTLE, PLASTIC	TABLET	180	26
43063-548-95	Lovastatin	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-548-14	EA - Each	43063-548	0cb6c0ff-b40d-42a0-88fc-2e3adc94d6dc	1	2015-01-05
43063-548-30	EA - Each	43063-548	d62a671c-cca5-4866-b78c-e4041d312c80	1	2015-01-05
43063-548-90	EA - Each	43063-548	c7fc47f8-789c-4fdf-bb2d-98d91b900ea5	1	2015-01-05
43063-548-95	EA - Each	43063-548	894aa3f9-825d-46d1-937c-f290dcbf961e	1	2022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-548	LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]	26	Current NDC, Legacy NDC, 5 package rows	20250305_eea93a4b-f804-4b9c-aabf-e906f03c1e80.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	9438d8a0-ca5b-4676-aab9-d0241ccff6c9	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals Inc.	56680dfa-abe6-4587-b222-364315fd78f4	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	ea4df37b-21e9-4dc3-83af-1be1b50bfdc9	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	7fd9d5c7-8025-4049-8b5b-ae3d22db507f	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	db47ddae-c574-427f-e053-2a95a90aae48	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	A-S Medication Solutions	dd7a223e-7fc5-4eb0-9bd7-2f9a2d6b4173	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	A-S Medication Solutions	bfb889a4-5751-4706-9fa7-f48672c1bc08	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	220a9b3c-c583-49e3-8bf0-d0c97dc9b829	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	c37206ae-52f1-4192-9ab9-3044247cf58d	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	ac86821f-d741-4ab1-bd03-ce8797dd4f34	2025-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	70e2bf86-4a78-4dfb-b6b1-8eb95f63684d	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	eea93a4b-f804-4b9c-aabf-e906f03c1e80	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991 ndc (product): 43063-548
Lovastatin	LOVASTATIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2eff3e5e-8746-048e-e063-6294a90a38c4	2025-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Carlsbad Technology, Inc.	0a680e13-0356-4e08-a7fe-78b96ba51b9d	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	c871a6a7-67a4-4ac1-b102-3f1604625c7d	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	415c2698-7787-49f8-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	4444573e-9df1-01e6-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	8d8199ca-df39-4eb8-a905-dee3ab7e2973	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	5684ceb8-a5b2-4fb4-92be-14aabcea3871	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	ad905651-6e3a-4140-aa37-d91e5f37c0f0	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075991 application number: ANDA075991

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	eea93a4b-f804-4b9c-aabf-e906f03c1e80	26
197905	lovastatin 40 MG Oral Tablet	SCD	eea93a4b-f804-4b9c-aabf-e906f03c1e80	26
197905	lovastatin 40 MG Oral Tablet	PSN	0399c35c-513d-48e6-aa20-e8434e3b18d5	1
197905	lovastatin 40 MG Oral Tablet	SCD	0399c35c-513d-48e6-aa20-e8434e3b18d5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-548-14	43063054814	14 TABLET in 1 BOTTLE, PLASTIC (43063-548-14)	14 tablet	2014-11-15	0000-00-00	No	No	Current
43063-548-30	43063054830	30 TABLET in 1 BOTTLE, PLASTIC (43063-548-30)	30 tablet	2014-11-15	0000-00-00	No	No	Current
43063-548-90	43063054890	90 TABLET in 1 BOTTLE, PLASTIC (43063-548-90)	90 tablet	2014-11-15	0000-00-00	No	No	Current
43063-548-93	43063054893	180 TABLET in 1 BOTTLE, PLASTIC (43063-548-93)	180 tablet	2014-12-24	0000-00-00	No	No	Current
43063-548-95	43063054895	1000 TABLET in 1 BOTTLE, PLASTIC (43063-548-95)	1000 tablet	2022-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lovastatin Tablet USP	PD-Rx Pharmaceuticals, Inc.	2025-02-28	HUMAN PRESCRIPTION DRUG LABEL	26
Lovastatin Tablet USP	Aphena Pharma Solutions - Tennessee, LLC	2024-01-23	HUMAN PRESCRIPTION DRUG LABEL	1