Pravastatin Sodium

Product NDC: 42658-106
11-digit product format: 426580106
Labeler code: 42658
Product ID: 42658-106_7cd14f0f-c4b6-6754-e053-2a91aa0a1b9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Hisun Pharmaceuiticals USA, Inc
Application: ANDA206061
Marketing category: ANDA
Marketing start: 2019-07-01
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: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42658-106		D	Discontinued by firm	2026-10-12
excluded package	package	42658-106	42658-106-04	D	Discontinued by firm	2026-10-12
excluded package	package	42658-106	42658-106-08	D	Discontinued by firm	2026-10-12

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 · 27 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42658-106-04	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42658-106-08	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42658-106-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42658-106-08	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42658-106-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42658-106-08	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42658-106-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42658-106-08	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42658-106-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42658-106-08	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42658-106-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42658-106-08	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42658-106-08	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42658-106-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42658-106-08	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42658-106-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42658-106-08	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42658-106-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A206061-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23
A206061-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23
A206061-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206061-002	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	2018-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206061-003	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	2018-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206061-001	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	2018-11-23	`301d65b070ca…`

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	A206061-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206061-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206061-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A206061-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206061-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206061-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206061-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206061-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206061-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206061-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206061-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206061-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206061-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206061-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206061-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206061-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206061-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206061-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42658-106-04	2025-01-30	C162847	48780-1	2cef2736-81ae-d83d-e063-dadaa90ab31f	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
42658-106-08	2025-01-30	C162847	48780-1	2cef2736-81ae-d83d-e063-dadaa90ab31f	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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42658-106	PRAVASTATIN SODIUM TABLET [HISUN PHARMACEUITICALS USA, INC]	6	Legacy NDC	20250101_d6bc3649-b3ee-44be-88f7-1ad18fdab0e8.zip

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	Hisun Pharmaceuiticals USA, Inc \| Hanhui Pharmaceuticals Co., Ltd.	2019-07-10	HUMAN PRESCRIPTION DRUG LABEL	6