Home NDC 71205-070 Simvastatin
Product NDC 71205-070
11-digit product format 712050070
Labeler code 71205
Product ID 71205-070_1bfa53ed-bcef-4864-81b9-e36a2016a7d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA076052
Marketing category ANDA
Marketing start 2006-06-27
Marketing end 0000-00-00
Substance SIMVASTATIN
Active strength 5 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71205-070-90 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71205-070-30 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71205-070-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71205-070-90 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71205-070-30 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71205-070-60 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076052-001 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 A076052-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 A076052-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 A076052-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 A076052-005 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL 2006-12-20
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 6 · 210 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 2026-08-18 06:07:40 2026-07 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 2680178bc6a6…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-070 SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP] 2 Legacy NDC 20191030_4615c9f1-04f5-4eb7-9a8d-cbb703772adb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71205-070-30 71205007030 30 TABLET, FILM COATED in 1 BOTTLE (71205-070-30) 2018-07-02 0000-00-00 No No Current 71205-070-60 71205007060 60 TABLET, FILM COATED in 1 BOTTLE (71205-070-60) 2018-07-02 0000-00-00 No No Current 71205-070-90 71205007090 90 TABLET, FILM COATED in 1 BOTTLE (71205-070-90) 2018-07-02 0000-00-00 No No Current