FDA.reportPublic FDA data

simvastatin

Product NDC
16729-006
11-digit product format
167290006
Labeler code
16729
Product ID
16729-006_43910ff2-6a21-bf9e-e063-6294a90a3f5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare, Inc.
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

Additional Listing Data#

Finished product
Yes
Brand name base
simvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211, 200345, 312961, 312962, 314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-006-10simvastatin30 in 1 BOTTLETABLET, FILM COATED3022
16729-006-12simvastatin60 in 1 BOTTLETABLET, FILM COATED6022
16729-006-15simvastatin90 in 1 BOTTLETABLET, FILM COATED9022
16729-006-17simvastatin1000 in 1 BOTTLETABLET, FILM COATED100022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-006SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]21Current NDC, Legacy NDC, 4 package rows20240719_871251c0-36a1-4a32-9eab-ff6c1e925ca9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSN356ed6a6-e467-4791-87ff-2ae7779fc1b01019
198211simvastatin 40 MG Oral TabletSCD356ed6a6-e467-4791-87ff-2ae7779fc1b01019
198211simvastatin 40 MG Oral TabletPSN7463b093-c2ee-49c3-a08a-e758de66422a29
198211simvastatin 40 MG Oral TabletSCD7463b093-c2ee-49c3-a08a-e758de66422a29
314231simvastatin 10 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
312961simvastatin 20 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
198211simvastatin 40 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
312962simvastatin 5 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
200345simvastatin 80 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
314231simvastatin 10 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
312961simvastatin 20 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
198211simvastatin 40 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
312962simvastatin 5 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
200345simvastatin 80 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
314231simvastatin 10 MG Oral TabletPSNe92b873a-0ccc-4852-845b-e27e5daab40e13
314231simvastatin 10 MG Oral TabletPSNf2a20844-9918-40f6-be69-6dea54b877a713
312961simvastatin 20 MG Oral TabletPSNf2a20844-9918-40f6-be69-6dea54b877a713
198211simvastatin 40 MG Oral TabletPSNe92b873a-0ccc-4852-845b-e27e5daab40e13
198211simvastatin 40 MG Oral TabletPSNf2a20844-9918-40f6-be69-6dea54b877a713
200345simvastatin 80 MG Oral TabletPSNe92b873a-0ccc-4852-845b-e27e5daab40e13
314231simvastatin 10 MG Oral TabletSCDf2a20844-9918-40f6-be69-6dea54b877a713
314231simvastatin 10 MG Oral TabletSCDe92b873a-0ccc-4852-845b-e27e5daab40e13
312961simvastatin 20 MG Oral TabletSCDf2a20844-9918-40f6-be69-6dea54b877a713
198211simvastatin 40 MG Oral TabletSCDf2a20844-9918-40f6-be69-6dea54b877a713
198211simvastatin 40 MG Oral TabletSCDe92b873a-0ccc-4852-845b-e27e5daab40e13
200345simvastatin 80 MG Oral TabletSCDe92b873a-0ccc-4852-845b-e27e5daab40e13
312961simvastatin 20 MG Oral TabletPSNe3a08f36-d80a-40e2-8572-d9b991b60c0d11
198211simvastatin 40 MG Oral TabletPSNe3a08f36-d80a-40e2-8572-d9b991b60c0d11
312961simvastatin 20 MG Oral TabletSCDe3a08f36-d80a-40e2-8572-d9b991b60c0d11
198211simvastatin 40 MG Oral TabletSCDe3a08f36-d80a-40e2-8572-d9b991b60c0d11
314231simvastatin 10 MG Oral TabletPSNca760e79-5d8c-4b36-9899-0d37e8e1f24e8
312961simvastatin 20 MG Oral TabletPSNca760e79-5d8c-4b36-9899-0d37e8e1f24e8
198211simvastatin 40 MG Oral TabletPSNca760e79-5d8c-4b36-9899-0d37e8e1f24e8
314231simvastatin 10 MG Oral TabletSCDca760e79-5d8c-4b36-9899-0d37e8e1f24e8
312961simvastatin 20 MG Oral TabletSCDca760e79-5d8c-4b36-9899-0d37e8e1f24e8
198211simvastatin 40 MG Oral TabletSCDca760e79-5d8c-4b36-9899-0d37e8e1f24e8
198211simvastatin 40 MG Oral TabletPSN54c236ce-69c2-06ef-e054-00144ff88e885
198211simvastatin 40 MG Oral TabletSCD54c236ce-69c2-06ef-e054-00144ff88e885
198211simvastatin 40 MG Oral TabletPSN9d0952e5-1172-4ef2-9c99-d2b3f8bace594
198211simvastatin 40 MG Oral TabletPSNf32d512f-86fa-b70f-e053-2a95a90afd014
198211simvastatin 40 MG Oral TabletSCD9d0952e5-1172-4ef2-9c99-d2b3f8bace594
198211simvastatin 40 MG Oral TabletSCDf32d512f-86fa-b70f-e053-2a95a90afd014
198211simvastatin 40 MG Oral TabletPSN48bc36db-f3c2-460a-8d11-13e5c576efeb3
198211simvastatin 40 MG Oral TabletPSN8e986df7-3020-6755-e053-2995a90aca373
198211simvastatin 40 MG Oral TabletSCD8e986df7-3020-6755-e053-2995a90aca373
198211simvastatin 40 MG Oral TabletSCD48bc36db-f3c2-460a-8d11-13e5c576efeb3
312961simvastatin 20 MG Oral TabletPSN597c10d1-76fb-1408-e053-2991aa0a78d22
312961simvastatin 20 MG Oral TabletPSN6fcd7ba3-02cd-41e9-85d5-494961155d3e2
198211simvastatin 40 MG Oral TabletPSNb5bebcd0-84e6-410d-af96-63834d262bad2
198211simvastatin 40 MG Oral TabletPSN6fcd7ba3-02cd-41e9-85d5-494961155d3e2
198211simvastatin 40 MG Oral TabletPSN597c10d1-76fb-1408-e053-2991aa0a78d22
312961simvastatin 20 MG Oral TabletSCD6fcd7ba3-02cd-41e9-85d5-494961155d3e2
312961simvastatin 20 MG Oral TabletSCD597c10d1-76fb-1408-e053-2991aa0a78d22
198211simvastatin 40 MG Oral TabletSCD6fcd7ba3-02cd-41e9-85d5-494961155d3e2
198211simvastatin 40 MG Oral TabletSCD597c10d1-76fb-1408-e053-2991aa0a78d22
198211simvastatin 40 MG Oral TabletSCDb5bebcd0-84e6-410d-af96-63834d262bad2
314231simvastatin 10 MG Oral TabletPSN0f878e82-7ce1-450b-abb0-2090c22b389b1
314231simvastatin 10 MG Oral TabletPSNef3c6f57-2729-4e32-8e7f-cd91d0cb713f1
314231simvastatin 10 MG Oral TabletPSN330e35ed-fd6b-4123-864a-a5aa339c24d61
312961simvastatin 20 MG Oral TabletPSN0f878e82-7ce1-450b-abb0-2090c22b389b1
312961simvastatin 20 MG Oral TabletPSNef3c6f57-2729-4e32-8e7f-cd91d0cb713f1
312961simvastatin 20 MG Oral TabletPSN330e35ed-fd6b-4123-864a-a5aa339c24d61
198211simvastatin 40 MG Oral TabletPSNef3c6f57-2729-4e32-8e7f-cd91d0cb713f1
198211simvastatin 40 MG Oral TabletPSN0f878e82-7ce1-450b-abb0-2090c22b389b1
198211simvastatin 40 MG Oral TabletPSN330e35ed-fd6b-4123-864a-a5aa339c24d61
198211simvastatin 40 MG Oral TabletPSNa3b22473-c221-43ad-98ec-3106e297cb831
200345simvastatin 80 MG Oral TabletPSN330e35ed-fd6b-4123-864a-a5aa339c24d61
314231simvastatin 10 MG Oral TabletSCD330e35ed-fd6b-4123-864a-a5aa339c24d61
314231simvastatin 10 MG Oral TabletSCDef3c6f57-2729-4e32-8e7f-cd91d0cb713f1
314231simvastatin 10 MG Oral TabletSCD0f878e82-7ce1-450b-abb0-2090c22b389b1
312961simvastatin 20 MG Oral TabletSCDef3c6f57-2729-4e32-8e7f-cd91d0cb713f1
312961simvastatin 20 MG Oral TabletSCD330e35ed-fd6b-4123-864a-a5aa339c24d61
312961simvastatin 20 MG Oral TabletSCD0f878e82-7ce1-450b-abb0-2090c22b389b1
198211simvastatin 40 MG Oral TabletSCDef3c6f57-2729-4e32-8e7f-cd91d0cb713f1
198211simvastatin 40 MG Oral TabletSCD330e35ed-fd6b-4123-864a-a5aa339c24d61
198211simvastatin 40 MG Oral TabletSCD0f878e82-7ce1-450b-abb0-2090c22b389b1
198211simvastatin 40 MG Oral TabletSCDa3b22473-c221-43ad-98ec-3106e297cb831
200345simvastatin 80 MG Oral TabletSCD330e35ed-fd6b-4123-864a-a5aa339c24d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-006-101672900061030 TABLET, FILM COATED in 1 BOTTLE (16729-006-10) 2008-02-260000-00-00NoNoCurrent
16729-006-121672900061260 in 1 BOTTLEHistorical
16729-006-151672900061590 TABLET, FILM COATED in 1 BOTTLE (16729-006-15) 2008-02-260000-00-00NoNoCurrent
16729-006-17167290006171000 TABLET, FILM COATED in 1 BOTTLE (16729-006-17) 2008-02-260000-00-00NoNoCurrent