pravastatin sodium

Product NDC
53808-0874
11-digit product format
538080874
Labeler code
53808
Product ID
53808-0874_dcafbc91-8eb4-4682-bf89-b16dd412be7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077751
Marketing category
ANDA
Marketing start
2013-01-01
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0874IInactivated by FDA2026-10-05
excluded packagepackage53808-087453808-0874-2IInactivated by FDA2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53808-0874-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0874-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0874-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0874-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0874-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0874-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0874-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0874-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0874-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0874-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0874-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0874-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0874-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0874-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0874-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0874-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0874-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0874-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0874-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0874-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0874-29bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077751-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30
A077751-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30
A077751-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30
A077751-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077751-002AB
A077751-003AB
A077751-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-001PRAVASTATIN SODIUM10MGTABLET / ORAL2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-04-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 133 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077751-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077751-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077751-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077751-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077751-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077751-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077751-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077751-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077751-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077751-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077751-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077751-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077751-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077751-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077751-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077751-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077751-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077751-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077751-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077751-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077751-002AB1301d65b070ca…

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 conceptRelationVersionEffective
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0874-2pravastatin sodium60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0874PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_5318e92a-aa98-4890-870e-e4dec3f6069e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN5318e92a-aa98-4890-870e-e4dec3f6069e1
904475pravastatin sodium 40 MG Oral TabletPSN5318e92a-aa98-4890-870e-e4dec3f6069e1
904467pravastatin sodium 20 MG Oral TabletSCD5318e92a-aa98-4890-870e-e4dec3f6069e1
904475pravastatin sodium 40 MG Oral TabletSCD5318e92a-aa98-4890-870e-e4dec3f6069e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0874-25380808740260 in 1 BLISTER PACKHistorical