FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
72789-316
11-digit product format
727890316
Labeler code
72789
Product ID
72789-316_4bbc599b-b925-6949-e063-6394a90ad9fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078103
Marketing category
ANDA
Marketing start
2007-06-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SIMVASTATIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui312961

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
72789-316-30SIMVASTATIN30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3020
72789-316-90SIMVASTATIN90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-316-30EA - Each72789-3167f7ea0f6-256d-43ee-905b-a0d6bce90b5f12023-06-06
72789-316-90EA - Each72789-316b12ee7d0-308f-4b9b-83fb-402a12d546a012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-316SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, 2 package rows20240220_143bf1d6-11c5-4a1f-b106-844e0435ee13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSN143bf1d6-11c5-4a1f-b106-844e0435ee1320
312961simvastatin 20 MG Oral TabletSCD143bf1d6-11c5-4a1f-b106-844e0435ee1320

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-316-307278903163030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-316-30) 2023-04-10NoNoCurrent
72789-316-907278903169090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-316-90) 2023-03-23NoNoCurrent