Home NDC 68788-9869 simvastatin
Product NDC 68788-9869
11-digit product format 687889869
Labeler code 68788
Product ID 68788-9869_a6a377c0-6795-4d61-8c65-678cfdf04aaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA078155
Marketing category ANDA
Marketing start 2012-02-28
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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 [PREFERRED PHARMACEUTICALS, INC.] 4 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9869 SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] 13 Legacy NDC 20240810_7442f35f-74e8-4c35-9666-190a3baad549.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 68788-9869-1 68788986901 100 TABLET, FILM COATED in 1 BOTTLE (68788-9869-1) 2012-02-28 0000-00-00 No No Current 68788-9869-3 68788986903 30 TABLET, FILM COATED in 1 BOTTLE (68788-9869-3) 2012-02-28 0000-00-00 No No Current 68788-9869-6 68788986906 60 TABLET, FILM COATED in 1 BOTTLE (68788-9869-6) 2012-02-28 0000-00-00 No No Current 68788-9869-9 68788986909 90 TABLET, FILM COATED in 1 BOTTLE (68788-9869-9) 2012-02-28 0000-00-00 No No Current