PRAVASTATIN SODIUM

Product NDC: 0615-7869
11-digit product format: 006157869
Labeler code: 0615
Product ID: 0615-7869_01ed1c4e-2e41-416b-8864-827f0680b760
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAVASTATIN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA076397
Marketing category: ANDA
Marketing start: 2014-04-28
Marketing end: 0000-00-00
Substance: PRAVASTATIN SODIUM
Active strength: 40 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#

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	0615-7869		D	Discontinued by firm		2026-08-11
excluded package	package	0615-7869	0615-7869-39	D	Discontinued by firm		2026-08-11

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7869-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7869-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7869-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7869-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7869-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7869-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7869-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7869-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7869-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7869-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7869-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7869-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7869-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7869-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7869-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog.

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
2019-12-13 00:20 UTC	2019-12	A076397-001	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076397-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076397-003	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076397-001	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076397-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076397-003	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076397-001	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076397-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076397-003	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076397-001	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076397-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076397-003	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076397-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076397-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076397-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076397-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076397-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076397-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076397-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076397-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076397-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076397-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076397-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076397-003	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-7869-39	2021-08-10	C162847	48780-1	9d75b9d0-0238-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use pravastatin sodium tablets, USP safely and effectively. See full prescribing information for pravastatin sodium tablets, USP . PRAVASTATIN sodium tablets, USP For oral use Initial U.S. Approval: 1991
0615-7869-39	2020-01-31	C162847	48780-1	9d75b9d0-0238-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use pravastatin sodium tablets, USP safely and effectively. See full prescribing information for pravastatin sodium tablets, USP . PRAVASTATIN sodium tablets, USP For oral use Initial U.S. Approval: 1991

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3M8608UQ61	PRAVASTATIN SODIUM	81131-70-6	PRAVASTATIN SODIUM

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRAVASTATIN SODIUM	NCS HealthCare of KY, Inc dba Vangard Labs	2015-01-23	HUMAN PRESCRIPTION DRUG LABEL	2