ZOCOR

Product NDC
78206-182
11-digit product format
782060182
Labeler code
78206
Product ID
78206-182_11256523-425c-48e8-afe1-e3a4e28c892e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Organon LLC
Application
NDA019766
Marketing category
NDA
Marketing start
2021-06-01
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
ZOCOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui104490, 104491, 152923, 198211, 312961, 314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
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
78206-182-01ZOCOR30 in 1 BOTTLETABLET, FILM COATED3011
78206-182-02ZOCOR90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-182ZOCOR (SIMVASTATIN) TABLET, FILM COATED [ORGANON LLC]11Current NDC, Legacy NDC, 2 package rows20250403_8f55d5de-5a4f-4a39-8c84-c53976dd6af9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN8f55d5de-5a4f-4a39-8c84-c53976dd6af911
312961simvastatin 20 MG Oral TabletPSN8f55d5de-5a4f-4a39-8c84-c53976dd6af911
198211simvastatin 40 MG Oral TabletPSN8f55d5de-5a4f-4a39-8c84-c53976dd6af911
104490Zocor 10 MG Oral TabletPSN8f55d5de-5a4f-4a39-8c84-c53976dd6af911
104491Zocor 20 MG Oral TabletPSN8f55d5de-5a4f-4a39-8c84-c53976dd6af911
152923Zocor 40 MG Oral TabletPSN8f55d5de-5a4f-4a39-8c84-c53976dd6af911
104490simvastatin 10 MG Oral Tablet [Zocor]SBD8f55d5de-5a4f-4a39-8c84-c53976dd6af911
104491simvastatin 20 MG Oral Tablet [Zocor]SBD8f55d5de-5a4f-4a39-8c84-c53976dd6af911
152923simvastatin 40 MG Oral Tablet [Zocor]SBD8f55d5de-5a4f-4a39-8c84-c53976dd6af911
314231simvastatin 10 MG Oral TabletSCD8f55d5de-5a4f-4a39-8c84-c53976dd6af911
312961simvastatin 20 MG Oral TabletSCD8f55d5de-5a4f-4a39-8c84-c53976dd6af911
198211simvastatin 40 MG Oral TabletSCD8f55d5de-5a4f-4a39-8c84-c53976dd6af911
104490Zocor 10 MG Oral TabletSY8f55d5de-5a4f-4a39-8c84-c53976dd6af911
104491Zocor 20 MG Oral TabletSY8f55d5de-5a4f-4a39-8c84-c53976dd6af911
152923Zocor 40 MG Oral TabletSY8f55d5de-5a4f-4a39-8c84-c53976dd6af911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78206-182-017820601820130 TABLET, FILM COATED in 1 BOTTLE (78206-182-01) 2021-06-010000-00-00NoNoCurrent
78206-182-027820601820290 TABLET, FILM COATED in 1 BOTTLE (78206-182-02) 2021-06-010000-00-00NoNoCurrent