PRAVASTATIN SODIUM

Product NDC: 60760-422
11-digit product format: 607600422
Labeler code: 60760
Product ID: 60760-422_7acbccac-3559-fe78-e053-2991aa0a69eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAVASTATIN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA207068
Marketing category: ANDA
Marketing start: 2018-03-06
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: No
Listing certified through: 2020-12-31
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	60760-422		D	Discontinued by firm		2026-08-11
excluded package	package	60760-422	60760-422-90	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60760-422-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60760-422-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60760-422-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60760-422-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60760-422-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60760-422-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60760-422-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60760-422-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60760-422-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60760-422-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60760-422-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60760-422-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A207068-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17
A207068-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17
A207068-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17
A207068-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A207068-001	AB
A207068-002	AB
A207068-003	AB
A207068-004	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 5 · 164 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	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A207068-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207068-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207068-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-422-90	EA - Each	60760-422	a11edc90-d49c-4f62-b761-0e154f43c214	1	2018-04-19

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	2ded7e5e-c377-4495-a045-f1c57b90c5db	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	46fdf929-c961-4dd9-8865-8eb4adaa259a	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	daacdad5-f75d-4f9f-b623-8071f3bef91e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Accord Healthcare Inc.	6c011348-a236-47d3-bbef-3e0b956dd080	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
Pravastatin Sodium	PRAVASTATIN SODIUM	Direct_Rx	7f814fd9-7b35-67da-e053-2a91aa0a39dc	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	63ca6179-6ae3-4f0b-bdca-50d200317921	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-422-90	60760042290	90 TABLET in 1 BOTTLE, PLASTIC (60760-422-90)	90 tablet	2018-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRAVASTATIN SODIUM	St. Mary's Medical Park Pharmacy \| Intas Pharmaceuticals Limited	2018-11-16	HUMAN PRESCRIPTION DRUG LABEL	2