Home NDC 60760-005 SIMVASTATIN
Product NDC 60760-005
11-digit product format 607600005
Labeler code 60760
Product ID 60760-005_f06d097e-228c-3973-e053-2995a90ad4c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler St Marys Medical Park Pharmacy
Application ANDA078155
Marketing category ANDA
Marketing start 2008-02-26
Marketing end 0000-00-00
Substance SIMVASTATIN
Active strength 20 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 9 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…
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60760-005 SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY] 11 Legacy NDC 20241213_a0714ce3-bd46-4536-9b1e-83489c368f40.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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60760-005-30 60760000530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-005-30) 2008-02-26 0000-00-00 No No Current 60760-005-90 60760000590 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-005-90) 2008-02-26 0000-00-00 No No Current