Home NDC 10544-907 simvastatin
Product NDC 10544-907
11-digit product format 105440907
Labeler code 10544
Product ID 10544-907_2421553d-ef12-4bab-95ba-30c7924a652a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA078155
Marketing category ANDA
Marketing start 2015-03-26
Marketing end 0000-00-00
Substance SIMVASTATIN
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 · 44 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 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-907-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10544-907-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10544-907-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10544-907-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10544-907-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10544-907-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-907-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-907-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-907-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-907-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-907-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-907-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-907-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-907-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-907-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-907-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-907-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-907-30 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-907-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…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 10544-907-30 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 10544-907-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10544-907-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A078155-001 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 A078155-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 A078155-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 A078155-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 A078155-005 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05
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 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 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.
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 10544-907-30 simvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-907 SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 1 package rows 20151125_8d63e5de-d89c-4d2a-970d-7d17f993b7fe.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 2 of 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join simvastatin SIMVASTATIN Aphena Pharma Solutions - Tennessee, LLC 121b0e00-abb7-4e07-a7b2-311be89fabb7 2019-03-25 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078155 application number: ANDA078155
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-907-30 10544090730 30 in 1 BOTTLE Historical