Home NDC 68071-4331 SIMVASTATIN
Product NDC 68071-4331
11-digit product format 680714331
Labeler code 68071
Product ID 68071-4331_2d3ff27f-de05-c79c-e063-6294a90a05c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SIMVASTATIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA078103
Marketing category ANDA
Marketing start 2007-06-12
Substance SIMVASTATIN
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 · 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 Code Status Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-4331-9 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-4331-9 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-4331-9 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…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 68071-4331-9 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078103-001 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 A078103-002 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 A078103-003 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 A078103-004 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 A078103-005 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 215 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 2026-09-14 22:38:34 2026-08 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base SIMVASTATIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIMVASTATIN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AGG2FN16EV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314231 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4331-9 SIMVASTATIN 90 in 1 BOTTLE TABLET, FILM COATED 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4331 SIMVASTATIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250205_673dfc44-d407-f9ac-e053-2a91aa0a4702.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 3 of 3 · 45 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68071-4331-9 68071433109 90 TABLET, FILM COATED in 1 BOTTLE (68071-4331-9) 2018-03-12 No No Current