Home NDC 31722-514 Simvastatin
Product NDC 31722-514
11-digit product format 317220514
Labeler code 31722
Product ID 31722-514_1553d57f-414d-2c66-e063-6294a90af8e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA200895
Marketing category ANDA
Marketing start 2014-12-09
Substance SIMVASTATIN
Active strength 80 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 1 .
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 A200895-001 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 A200895-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 A200895-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 A200895-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 A200895-005 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25
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 · 205 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 2026-02-19 14:30 UTC 2026-02 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 205 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Simvastatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIMVASTATIN 80 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198211 Internal RxNorm lookup 200345 Internal RxNorm lookup 312961 Internal RxNorm lookup 312962 Internal RxNorm lookup 314231 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 31722-514-01 Simvastatin 100 in 1 BOTTLE TABLET, FILM COATED 100 10 31722-514-05 Simvastatin 500 in 1 BOTTLE TABLET, FILM COATED 500 10 31722-514-30 Simvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 10 31722-514-90 Simvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 HYDROXYPROPYL CELLULOSE (Type H) INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-514 SIMVASTATIN (SIMVASTATIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 4 package rows 20240406_751b79c6-bba8-4d29-b69c-a2ac6453fec8.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 1 of 1 · 3 matching rows.
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 31722-514-01 31722051401 100 TABLET, FILM COATED in 1 BOTTLE (31722-514-01) 2014-12-09 0000-00-00 No No Current 31722-514-05 31722051405 500 TABLET, FILM COATED in 1 BOTTLE (31722-514-05) 2014-12-09 0000-00-00 No No Current 31722-514-30 31722051430 30 TABLET, FILM COATED in 1 BOTTLE (31722-514-30) 2014-12-09 0000-00-00 No No Current 31722-514-90 31722051490 90 TABLET, FILM COATED in 1 BOTTLE (31722-514-90) 2014-12-09 0000-00-00 No No Current