PRAVASTATIN SODIUM

Product NDC: 82868-104
Requested package NDC: 82868-104-30
11-digit product format: 828680104
Labeler code: 82868
Product ID: 82868-104_4fad51aa-7705-438c-e063-6294a90ae565
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAVASTATIN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA076341
Marketing category: ANDA
Marketing start: 2026-04-16
Substance: PRAVASTATIN SODIUM
Active strength: 10 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A076341-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23
A076341-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23
A076341-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23
A076341-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076341-001	AB
A076341-002	AB
A076341-003	AB
A076341-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076341-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076341-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076341-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076341-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: PRAVASTATIN SODIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAVASTATIN SODIUM	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3M8608UQ61	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904458	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4fad5d73-aa79-58f2-e063-6294a90af4aa	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82868-104-30	PRAVASTATIN SODIUM	30 in 1 BOTTLE, PLASTIC	TABLET	30		1

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	5ecd9fd1-7662-412d-99c5-13c77188748c	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	6d42bd30-1f09-49f4-9ec8-31366df1b4b4	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	46cdd32d-a022-4acf-ba2b-10e7877d56c6	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc..	ebd794ba-90c3-4d81-9c45-4aa9d9454359	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	3e218ad6-5b47-4cca-81be-ebaea5795964	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Quallent	e9c188f7-cd6f-afac-b493-36552d86589e	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Apotex Corp.	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5f611aa-9974-422e-a353-5d834a33937c	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	8dbdc80d-9d8c-4e22-9108-d87a77e07a6b	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	14390bfa-3bcb-43e1-936c-1977cb37427d	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	8d1bf7a5-bf11-47e3-afca-dcc13f2d3068	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	4fad5d73-aa79-58f2-e063-6294a90af4aa	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341 ndc (package): 82868-104-30 ndc (product): 82868-104 ndc11 (package): 82868010430
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	93b0e546-9e0f-40d1-9b1e-082bf16400a4	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	d69e8af8-dbd4-43d9-8e9a-4aed3923a17c	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f4b330ce-dfb0-4e4e-9f37-482458820c66	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	64ccb4b5-b77e-4b23-8c74-4685287edb4b	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	c0b1b483-1a19-4966-89b1-118ec660f203	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ba4ac602-46fa-8386-e053-2995a90a9764	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341

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
904458	pravastatin sodium 10 MG Oral Tablet	PSN	4fad5d73-aa79-58f2-e063-6294a90af4aa	1
904458	pravastatin sodium 10 MG Oral Tablet	SCD	4fad5d73-aa79-58f2-e063-6294a90af4aa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82868-104-30	82868010430	30 TABLET in 1 BOTTLE, PLASTIC (82868-104-30)	30 tablet	2026-04-16	No	No	Current