Altoprev

Product NDC: 70515-630
11-digit product format: 705150630
Labeler code: 70515
Product ID: 70515-630_6ae2aacf-9571-4194-ac9a-14e29cd9061a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lovastatin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Covis Pharma US, Inc
Application: NDA021316
Marketing category: NDA
Marketing start: 2016-05-01
Marketing end: 0000-00-00
Substance: LOVASTATIN
Active strength: 60 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70515-630		D	Discontinued by firm		2026-10-05
excluded package	package	70515-630	70515-630-30	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70515-630		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70515-630	70515-630-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021316-001	ALTOPREV	LOVASTATIN	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26
N021316-002	ALTOPREV	LOVASTATIN	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26
N021316-003	ALTOPREV	LOVASTATIN	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26
N021316-004	ALTOPREV	LOVASTATIN	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70515-630-30	EA - Each	70515-630	2ad771cd-1a93-4455-95a4-0c1666776e0f	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70515-630	ALTOPREV (LOVASTATIN) TABLET, EXTENDED RELEASE [COVIS PHARMA US, INC]	8	Legacy NDC	20250115_8c0db100-5df9-49c3-8af9-1bc03ae609b9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9LHU78OQFD	LOVASTATIN	75330-75-5	LOVASTATIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70515-630-30	70515063030	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70515-630-30)	2016-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Altoprev	Covis Pharma US, Inc \| Actavis Laboratories FL, Inc.	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	8