Home NDC 63629-3385-2 simvastatin
Product NDC 63629-3385
Requested package NDC 63629-3385-2
11-digit product format 636293385
Labeler code 63629
Product ID 63629-3385_cdc60a7b-745c-4fd8-b2b2-119faba93348
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078155
Marketing category ANDA
Marketing start 2008-02-26
Substance SIMVASTATIN
Active strength 40 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 220 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 2026-10-15 13:18:30 2026-09 A078155-001 SIMVASTATIN 80MG TABLET / ORAL AB 2008-02-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078155-002 SIMVASTATIN 10MG TABLET / ORAL AB 2008-02-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078155-003 SIMVASTATIN 20MG TABLET / ORAL AB 2008-02-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078155-004 SIMVASTATIN 40MG TABLET / ORAL AB 2008-02-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078155-005 SIMVASTATIN 5MG TABLET / ORAL AB 2013-04-05 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 220 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 40 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 198211 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-3385-1 simvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 1019 63629-3385-2 simvastatin 60 in 1 BOTTLE TABLET, FILM COATED 60 1019 63629-3385-3 simvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 1019 63629-3385-4 simvastatin 180 in 1 BOTTLE TABLET, FILM COATED 180 1019 63629-3385-5 simvastatin 100 in 1 BOTTLE TABLET, FILM COATED 100 1019 63629-3385-6 simvastatin 120 in 1 BOTTLE TABLET, FILM COATED 120 1019 63629-3385-7 simvastatin 28 in 1 BOTTLE TABLET, FILM COATED 28 1019 63629-3385-8 simvastatin 10 in 1 BOTTLE TABLET, FILM COATED 10 1019
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-3385 SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1019 Current NDC, Legacy NDC, 8 package rows 20240820_356ed6a6-e467-4791-87ff-2ae7779fc1b0.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 Marketing start Marketing end Sample Exclude flag Status 63629-3385-2 63629338502 60 TABLET, FILM COATED in 1 BOTTLE (63629-3385-2) 2009-06-15 0000-00-00 No No Current