PRAVASTATIN SODIUM

Product NDC
68180-485
11-digit product format
681800485
Labeler code
68180
Product ID
68180-485_a173dd76-57cb-4066-a51f-26adfb79e861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAVASTATIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA077917
Marketing category
ANDA
Marketing start
2008-07-24
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
2026-12-31
Current FDA listing
Yes

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 packagepackage68180-48568180-485-02DDiscontinued by firm2026-08-03
excluded packagepackage68180-48568180-485-09DDiscontinued by firm2026-08-03

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0568180-485-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0568180-485-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2668180-485-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2668180-485-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3168180-485-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3168180-485-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2868180-485-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2868180-485-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2168180-485-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2168180-485-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1068180-485-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1068180-485-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3168180-485-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3168180-485-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2068180-485-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2068180-485-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1068180-485-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1068180-485-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0868180-485-09ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0868180-485-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0368180-485-09367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0368180-485-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0968180-485-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0968180-485-02557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077917-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-08
A077917-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-08
A077917-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-08
A077917-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077917-001AB
A077917-002AB
A077917-003AB
A077917-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077917-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2008-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077917-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2008-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077917-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2008-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077917-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2008-01-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077917-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077917-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077917-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077917-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077917-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077917-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077917-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077917-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077917-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077917-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077917-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077917-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077917-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077917-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077917-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077917-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077917-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077917-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077917-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077917-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077917-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077917-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077917-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077917-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077917-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077917-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077917-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077917-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077917-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077917-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077917-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077917-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077917-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077917-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077917-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077917-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077917-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077917-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077917-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077917-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
PRAVASTATIN SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAVASTATIN SODIUM10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3M8608UQ61Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904458Internal RxNorm lookup
904467Internal RxNorm lookup
904475Internal RxNorm lookup
904481Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1123d56c-16f0-4f81-b56f-67b1f343ae1eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
36361c23-a766-1581-d616-2080c781a50cProduct name520190314
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-485-02PRAVASTATIN SODIUM500 in 1 BOTTLETABLET50012
68180-485-03PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET100012
68180-485-09PRAVASTATIN SODIUM90 in 1 BOTTLETABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-485-02EA - Each68180-4854dae3057-f325-4f1d-9cec-7f925dfe0fbf12012-07-24
68180-485-09EA - Each68180-485bb5909e5-ad9f-4d2c-a787-90d94e5e20ee12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-485PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 3 package rows20231221_1123d56c-16f0-4f81-b56f-67b1f343ae1e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin SodiumPRAVASTATIN SODIUMChartwell RX, LLCf87016fb-4c01-4279-8cf7-59819971ca152025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077917
application number: ANDA077917
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack24471777-5cd6-4c46-a5f2-a349fadc830e2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077917
application number: ANDA077917
PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.1123d56c-16f0-4f81-b56f-67b1f343ae1e2023-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077917
application number: ANDA077917
ndc (product): 68180-485

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904458pravastatin sodium 10 MG Oral TabletPSN1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904467pravastatin sodium 20 MG Oral TabletPSN1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904475pravastatin sodium 40 MG Oral TabletPSN1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904481pravastatin sodium 80 MG Oral TabletPSN1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904458pravastatin sodium 10 MG Oral TabletSCD1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904467pravastatin sodium 20 MG Oral TabletSCD1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904475pravastatin sodium 40 MG Oral TabletSCD1123d56c-16f0-4f81-b56f-67b1f343ae1e12
904481pravastatin sodium 80 MG Oral TabletSCD1123d56c-16f0-4f81-b56f-67b1f343ae1e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-485-0268180048502500 TABLET in 1 BOTTLE (68180-485-02) 500 tablet2008-07-240000-00-00NoNoCurrent
68180-485-03681800485031000 TABLET in 1 BOTTLE (68180-485-03) 1000 tablet2008-07-240000-00-00NoNoCurrent
68180-485-096818004850990 TABLET in 1 BOTTLE (68180-485-09) 90 tablet2008-07-240000-00-00NoNoCurrent