Home NDC 0615-7570 Pravastatin
Product NDC 0615-7570
11-digit product format 006157570
Labeler code 0615
Product ID 0615-7570_a6771890-b58f-4154-b584-9a145c6fd77c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pravastatin Sodium
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA076714
Marketing category ANDA
Marketing start 2006-10-23
Marketing end 0000-00-00
Substance PRAVASTATIN SODIUM
Active strength 80 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-7570-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-7570-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-7570-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-7570-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-7570-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-7570-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-7570-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-7570-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-7570-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-7570-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-7570-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-7570-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-7570-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-7570-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-7570-39 I Inactivated by FDA 110d247fa046…a55b01930146…
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 A076714-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 A076714-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 A076714-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 A076714-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28
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 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076714-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076714-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076714-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076714-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAVASTATIN SODIUM ACTIVE INGREDIENT 3M8608UQ61 PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 PRAVASTATIN ACTIVE MOIETY KXO2KT9N0G PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MEGLUMINE INACTIVE INGREDIENT 6HG8UB2MUY PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PRAVASTATIN (PRAVASTATIN SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1
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.