Home NDC 68180-485-09 PRAVASTATIN SODIUM
Product NDC 68180-485
Requested package NDC 68180-485-09
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 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 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 RLD / RS Approval date A077917-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 A077917-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 A077917-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 A077917-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077917-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2008-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077917-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2008-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077917-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2008-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077917-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2008-01-08 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PRAVASTATIN SODIUM
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904458 Internal RxNorm lookup 904467 Internal RxNorm lookup 904475 Internal RxNorm lookup 904481 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-485-02 PRAVASTATIN SODIUM 500 in 1 BOTTLE TABLET 500 12 68180-485-03 PRAVASTATIN SODIUM 1000 in 1 BOTTLE TABLET 1000 12 68180-485-09 PRAVASTATIN SODIUM 90 in 1 BOTTLE TABLET 90 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-485 PRAVASTATIN SODIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 12 Current NDC, Legacy NDC, 3 package rows 20231221_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-485-09 68180048509 90 TABLET in 1 BOTTLE (68180-485-09) 90 tablet 2008-07-24 0000-00-00 No No Current