Pravastatin Sodium

Product NDC: 50090-5927
Requested package NDC: 50090-5927-1
11-digit product format: 500905927
Labeler code: 50090
Product ID: 50090-5927_5651e289-114d-4e4f-831c-c369c7148af1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077793
Marketing category: ANDA
Marketing start: 2008-09-29
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-5927	50090-5927-1	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077793-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077793-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB		2008-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB		2008-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB		2008-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB		2008-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB		2008-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB		2008-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB		2008-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB		2008-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077793-001	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	RS	2008-01-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A077793-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077793-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077793-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077793-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077793-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077793-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077793-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077793-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077793-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077793-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077793-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077793-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077793-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077793-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077793-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077793-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077793-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077793-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077793-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077793-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077793-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077793-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077793-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077793-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077793-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077793-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077793-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077793-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077793-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077793-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077793-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077793-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077793-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077793-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077793-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077793-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077793-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077793-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077793-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077793-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36361c23-a766-1581-d616-2080c781a50c	Product name	5	20190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5927-0	2024-01-30	C162847	48780-1	1030e365-01fe-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-5927-1	2024-01-30	C162847	48780-1	1030e365-01fe-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5927-0	Pravastatin Sodium	30 in 1 BOTTLE	TABLET	30		1
50090-5927-1	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
50090-5927-0	EA - Each	50090-5927	92e82af7-4c3b-416b-a8b2-5a316d537906	1	2022-06-06
50090-5927-1	EA - Each	50090-5927	23e07edc-479c-41f7-a122-7789decf5d8b	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5927	PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 2 package rows	20220303_72f8a4bc-f921-4f28-b2f4-0f4433430885.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin sodium	PRAVASTATIN SODIUM	Aurobindo Pharma Limited	c21d4797-d252-4073-891f-330484c5f643	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077793 application number: ANDA077793
Pravastatin Sodium	PRAVASTATIN SODIUM	Teva Pharmaceuticals, Inc.	f66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b8	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077793 application number: ANDA077793

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	72f8a4bc-f921-4f28-b2f4-0f4433430885	1
904481	pravastatin sodium 80 MG Oral Tablet	SCD	72f8a4bc-f921-4f28-b2f4-0f4433430885	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5927-1	50090592701	90 TABLET in 1 BOTTLE (50090-5927-1)	90 tablet	2022-03-01	0000-00-00	No	No	Current