PRAVASTATIN SODIUM

Product NDC: 61919-801
Requested package NDC: 61919-801-90
11-digit product format: 619190801
Labeler code: 61919
Product ID: 61919-801_ea4ec601-5971-1928-e053-2995a90adc38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAVASTATIN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA077751
Marketing category: ANDA
Marketing start: 2019-10-04
Marketing end: 0000-00-00
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: 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	61919-801	61919-801-90	D	Discontinued by firm		2026-10-05

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 · 12 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…`

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
A077751-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30
A077751-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30
A077751-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30
A077751-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077751-002	AB
A077751-003	AB
A077751-004	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	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 133 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	A077751-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077751-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077751-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077751-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077751-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077751-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077751-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077751-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077751-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077751-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077751-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077751-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077751-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077751-002	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

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
61919-801-90	Pravastatin Sodium	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-801-30	EA - Each	61919-801	3ccfe33c-4128-4e3c-bfbb-2d8df440f904	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-801	PRAVASTATIN SODIUM TABLET [DIRECT_RX]	3	Legacy NDC, 1 package rows	20240111_7f814fd9-7b35-67da-e053-2a91aa0a39dc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin Sodium	PRAVASTATIN SODIUM	Direct_Rx	7f814fd9-7b35-67da-e053-2a91aa0a39dc	2024-01-10	Warnings, Adverse reactions	Exact identifier ndc (package): 61919-801-90 ndc (product): 61919-801 ndc11 (package): 61919080190

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	7f814fd9-7b35-67da-e053-2a91aa0a39dc	3
904475	pravastatin sodium 40 MG Oral Tablet	PSN	7f814fd9-7b35-67da-e053-2a91aa0a39dc	3
904467	pravastatin sodium 20 MG Oral Tablet	SCD	7f814fd9-7b35-67da-e053-2a91aa0a39dc	3
904475	pravastatin sodium 40 MG Oral Tablet	SCD	7f814fd9-7b35-67da-e053-2a91aa0a39dc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-801-90	61919080190	90 TABLET in 1 BOTTLE (61919-801-90)	90 tablet	2019-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pravastatin Sodium	Direct_Rx	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	3
PRAVASTATIN SODIUM	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2