Pravastatin Sodium

Product NDC: 61919-734
11-digit product format: 619190734
Labeler code: 61919
Product ID: 61919-734_7f80cd52-26f8-34ed-e053-2a91aa0adf47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA207068
Marketing category: ANDA
Marketing start: 2019-01-15
Marketing end: 0000-00-00
Substance: PRAVASTATIN SODIUM
Active strength: 80 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	61919-734		I	Inactivated by FDA		2026-08-11
excluded package	package	61919-734	61919-734-90	I	Inactivated by FDA		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 · 38 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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`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	61919-734-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-734-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-734-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-734-90	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-734-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-734-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-734-90	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-734-90	`8dfbde2a14a4…`	`c9ff85d89658…`

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
36361c23-a766-1581-d616-2080c781a50c	Product name	5	20190314
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-734-90	2021-01-29	C162847	48780-1	ba0f9c33-0f70-a910-e053-dadaa90a0b85	Pravastatin Sodium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-734-90	Pravastatin Sodium	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-734-90	EA - Each	61919-734	226bbc98-8818-42d5-882f-a6357b0cc16d	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-734	PRAVASTATIN SODIUM TABLET [DIRECT_RX]	1	Legacy NDC, 1 package rows	20190214_7f80cd52-26f7-34ed-e053-2a91aa0adf47.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904481	pravastatin sodium 80 MG Oral Tablet	PSN	7f80cd52-26f7-34ed-e053-2a91aa0adf47	1
904481	pravastatin sodium 80 MG Oral Tablet	SCD	7f80cd52-26f7-34ed-e053-2a91aa0adf47	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-734-90	61919073490	90 in 1 BOTTLE	Historical