Lovastatin

Product NDC: 68788-9181
11-digit product format: 687889181
Labeler code: 68788
Product ID: 68788-9181_84e34b24-b38d-4c7a-ac35-1542df41185b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lovastatin
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc
Application: ANDA075828
Marketing category: ANDA
Marketing start: 2005-10-27
Marketing end: 0000-00-00
Substance: LOVASTATIN
Active strength: 20 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9181		I	Inactivated by FDA	2026-07-31
excluded package	package	68788-9181	68788-9181-1	I	Inactivated by FDA	2026-07-31
excluded package	package	68788-9181	68788-9181-3	I	Inactivated by FDA	2026-07-31
excluded package	package	68788-9181	68788-9181-6	I	Inactivated by FDA	2026-07-31
excluded package	package	68788-9181	68788-9181-9	I	Inactivated by FDA	2026-07-31

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
A075828-001	LOVASTATIN	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17
A075828-002	LOVASTATIN	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17
A075828-003	LOVASTATIN	LOVASTATIN	40MG	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
A075828-001	AB
A075828-002	AB
A075828-003	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	A075828-001	LOVASTATIN	10MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075828-002	LOVASTATIN	20MG	TABLET / ORAL	AB	2001-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075828-003	LOVASTATIN	40MG	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	A075828-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075828-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075828-003	AB	1	`a50c72e98297…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68788-9181-1	2020-01-31	C162847	48780-1	9d75b9d0-c859-f424-e053-dadaa90a57ce	LOVASTATIN TABLETS, USP
68788-9181-3	2020-01-31	C162847	48780-1	9d75b9d0-c859-f424-e053-dadaa90a57ce	LOVASTATIN TABLETS, USP
68788-9181-6	2020-01-31	C162847	48780-1	9d75b9d0-c859-f424-e053-dadaa90a57ce	LOVASTATIN TABLETS, USP
68788-9181-9	2020-01-31	C162847	48780-1	9d75b9d0-c859-f424-e053-dadaa90a57ce	LOVASTATIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-9181-1	Lovastatin	100 in 1 BOTTLE, DISPENSING	TABLET	100	3
68788-9181-3	Lovastatin	30 in 1 BOTTLE, DISPENSING	TABLET	30	3
68788-9181-6	Lovastatin	60 in 1 BOTTLE, DISPENSING	TABLET	60	3
68788-9181-9	Lovastatin	90 in 1 BOTTLE, DISPENSING	TABLET	90	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOVASTATIN	ACTIVE INGREDIENT	9LHU78OQFD	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	2
LOVASTATIN	ACTIVE MOIETY	9LHU78OQFD	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9181	LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]	3	Legacy NDC, 4 package rows	20161230_f5766e3f-374d-47b5-b141-2767cb7a4693.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
197904	lovastatin 20 MG Oral Tablet	PSN	f5766e3f-374d-47b5-b141-2767cb7a4693	3
197904	lovastatin 20 MG Oral Tablet	SCD	f5766e3f-374d-47b5-b141-2767cb7a4693	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68788-9181-1	68788918101	100 in 1 BOTTLE, DISPENSING	Historical
68788-9181-3	68788918103	30 in 1 BOTTLE, DISPENSING	Historical
68788-9181-6	68788918106	60 in 1 BOTTLE, DISPENSING	Historical
68788-9181-9	68788918109	90 in 1 BOTTLE, DISPENSING	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOVASTATIN TABLETS, USP	Preferred Pharmaceuticals, Inc	2016-12-30	HUMAN PRESCRIPTION DRUG LABEL	3