Pravastatin sodium

Product NDC: 50090-7893
11-digit product format: 500907893
Labeler code: 50090
Product ID: 50090-7893_198ed1f2-176c-498c-8f5c-2083be295b61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin sodium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA209869
Marketing category: ANDA
Marketing start: 2021-02-01
Substance: PRAVASTATIN SODIUM
Active strength: 20 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 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
A209869-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13
A209869-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13
A209869-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13
A209869-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209869-001	AB
A209869-002	AB
A209869-003	AB
A209869-004	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	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`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	A209869-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209869-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209869-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209869-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209869-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209869-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209869-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209869-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209869-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209869-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209869-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209869-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209869-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209869-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209869-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209869-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209869-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209869-004	AB	1	`d06236e962d9…`

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	20 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
904467	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
2f658680-939a-4212-8a5e-a44a896dd221	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7893-0	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
50090-7893-0	EA - Each	50090-7893	df12a817-c5e1-4fef-b4e6-81a6edf8cadf	1	2026-03-17

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ca7a4143-0091-4cd5-9061-cb05cc84ea4e	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	3686a2df-51c4-4f1c-9d1e-d69207915144	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	d0641def-425e-4357-a6b6-24ce00424549	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	dcf46d0c-87da-4009-b238-eb5cf287c3ed	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Golden State Medical Supply, Inc.	25b7276e-a69f-af63-e063-6394a90aecf2	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Biocon Pharma Inc.	9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	2f658680-939a-4212-8a5e-a44a896dd221	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (product): 50090-7893
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	3b9fe7c9-791e-49a0-a005-ccf13036c365	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	40aa2d36-57ce-1f48-e063-6294a90affef	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	47207487-0c6d-8da3-e063-6294a90a8aee	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	4ed7a4d1-1183-4d95-8311-6d3e58feafa8	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	33c141e9-76dc-4e32-9b2a-4621f32ac4bd	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	72693449-01ee-42b0-9902-566252324579	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	7b7f5c28-78fa-4625-ad69-4291500e033d	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	51800012-406b-4389-817f-88dd21e338d1	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	a7f75948-2958-44c8-b52f-5e39e80cdd1f	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	e358f314-9cbe-46a4-9564-6bedc7ef9d59	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	80ddec55-6a18-4b87-8a07-6ae86ad62853	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869

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
904467	pravastatin sodium 20 MG Oral Tablet	PSN	2f658680-939a-4212-8a5e-a44a896dd221	1
904467	pravastatin sodium 20 MG Oral Tablet	SCD	2f658680-939a-4212-8a5e-a44a896dd221	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7893-0	50090789300	90 TABLET in 1 BOTTLE (50090-7893-0)	90 tablet	2026-02-09	No	No	Current