Pravastatin Sodium

Product NDC: 0615-6556
11-digit product format: 006156556
Labeler code: 0615
Product ID: 0615-6556_18862fca-d643-474b-b1af-6af180f2c45f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA076056
Marketing category: ANDA
Marketing start: 2011-07-22
Marketing end: 0000-00-00
Substance: PRAVASTATIN SODIUM
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#

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	0615-6556		D	Discontinued by firm		2026-08-03
excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm		2026-08-03

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	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0615-6556		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-6556	0615-6556-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	0615-6556		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-6556	0615-6556-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	0615-6556		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-6556	0615-6556-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	0615-6556		I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-6556	0615-6556-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
A076056-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24
A076056-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24
A076056-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076056-001	AB
A076056-002	AB
A076056-003	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	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`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	A076056-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076056-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076056-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076056-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076056-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076056-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076056-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076056-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076056-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076056-001	AB	1	`8072bd15b7f6…`

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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin Sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	0c4b59f1-92a8-44f8-8b4c-691f35777460	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	ca779f66-4b9d-41da-ad0e-e4f58db9fbac	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Safecor Health LLC	0ae196a4-be3d-4cd8-9ff2-68aeb91b8678	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	b7f8c679-a602-4268-81b6-962a136a4e43	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	8df47d82-5b09-414d-99f1-7ac4c77f7c01	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	f6ddb6c0-d0b4-2297-e053-6294a90a83c9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	471b4dac-057d-740c-e063-6294a90af9e9	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	f92e12bc-40c3-4afa-9190-2f4de11ec6b3	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	e6a3d99c-c9cc-49d9-b0f9-503770307b70	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	3ef390a6-e0a0-331d-e063-6394a90a83d0	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	fa152ce7-6c07-4aaf-9374-932ce81d0cf9	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	6cef5e92-26b7-435c-878f-72a05a624560	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	7abc1825-182d-40bc-9f7f-968e197b4246	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Mylan Institutional Inc.	1b00f510-c86d-46f6-b427-311a8fd14955	2025-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Aurobindo Pharma Limited	cf6f7031-33b9-40d3-bc87-32f1b6af98f2	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	2d40e473-f79a-e50e-e063-6294a90a4d9e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	55f8cf43-bf8b-4729-9e5a-32fcc9696e02	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Teva Pharmaceuticals USA, Inc.	99e0e848-f8f3-4b42-b880-8fbc42633948	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	4f9ada33-5592-4780-926d-1af49a8e064e	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Proficient Rx LP	466e2d1a-a6d6-40f8-a9f6-3e7494a34ca6	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-6556-39	2021-08-10	C162847	48780-1	97449f38-cfb6-f6ea-e053-dbdaa90aa703	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
0615-6556-39	2019-11-13	C162847	48780-1	97449f38-cfb6-f6ea-e053-dbdaa90aa703	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 PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM TABLET PRAVASTATIN SODIUM (PRAVASTAIN 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	2012-02-15	HUMAN PRESCRIPTION DRUG LABEL	2