FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
68180-464
11-digit product format
681800464
Labeler code
68180
Product ID
68180-464_b78d4e8a-2261-43c6-9321-ac2539bdfd2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078103
Marketing category
ANDA
Marketing start
2016-02-19
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
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
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
68180-464-03SIMVASTATIN1000 in 1 BOTTLETABLET, FILM COATED100023
68180-464-06SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED3023
68180-464-09SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-464-03EA - Each68180-4640821ffcb-457f-433a-adb6-91da3eefef5512016-03-04
68180-464-06EA - Each68180-464a80faa53-6fb3-4182-a295-efe33d81bf2712016-09-02
68180-464-09EA - Each68180-464a128eb07-9252-486c-85d8-9d52b99b796612016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-464SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 3 package rows20250515_3e48217f-8175-4e9b-9fd0-909be4bbba95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSN7abc03f8-9d5f-4f7d-9e32-fc463ec0597c103
198211simvastatin 40 MG Oral TabletSCD7abc03f8-9d5f-4f7d-9e32-fc463ec0597c103
314231simvastatin 10 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
312961simvastatin 20 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
198211simvastatin 40 MG Oral TabletPSN00896fff-081d-4553-be8c-1999a8a73dda23
198211simvastatin 40 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
312962simvastatin 5 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
200345simvastatin 80 MG Oral TabletPSN3e48217f-8175-4e9b-9fd0-909be4bbba9523
314231simvastatin 10 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
312961simvastatin 20 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
198211simvastatin 40 MG Oral TabletSCD00896fff-081d-4553-be8c-1999a8a73dda23
198211simvastatin 40 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
312962simvastatin 5 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
200345simvastatin 80 MG Oral TabletSCD3e48217f-8175-4e9b-9fd0-909be4bbba9523
198211simvastatin 40 MG Oral TabletPSN3b0720d2-b240-48e4-af77-9ccda509fae712
198211simvastatin 40 MG Oral TabletSCD3b0720d2-b240-48e4-af77-9ccda509fae712
198211simvastatin 40 MG Oral TabletPSN51dd8d34-e660-49dc-a86e-07d031a1846511
198211simvastatin 40 MG Oral TabletSCD51dd8d34-e660-49dc-a86e-07d031a1846511
198211simvastatin 40 MG Oral TabletPSNe59bf31f-d880-4d9e-b6c2-5a18a53718f910
198211simvastatin 40 MG Oral TabletSCDe59bf31f-d880-4d9e-b6c2-5a18a53718f910
198211simvastatin 40 MG Oral TabletPSNd099d003-4c7c-4e35-ad6e-94ddf20035b79
198211simvastatin 40 MG Oral TabletSCDd099d003-4c7c-4e35-ad6e-94ddf20035b79
198211simvastatin 40 MG Oral TabletPSN8850724a-a431-46e5-b88e-1d77b0b62d6e7
198211simvastatin 40 MG Oral TabletSCD8850724a-a431-46e5-b88e-1d77b0b62d6e7
314231simvastatin 10 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
312961simvastatin 20 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
198211simvastatin 40 MG Oral TabletPSN7649bec7-04c6-47b5-a050-15923006dac04
198211simvastatin 40 MG Oral TabletPSNf71f71db-e0dd-6609-e053-6294a90a44504
198211simvastatin 40 MG Oral TabletPSN0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
314231simvastatin 10 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
312961simvastatin 20 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
198211simvastatin 40 MG Oral TabletSCD7649bec7-04c6-47b5-a050-15923006dac04
198211simvastatin 40 MG Oral TabletSCDf71f71db-e0dd-6609-e053-6294a90a44504
198211simvastatin 40 MG Oral TabletSCD0901f56b-07dd-4e33-a13d-2a047d5c5f5b4
198211simvastatin 40 MG Oral TabletPSNf94d5907-737e-df67-e053-6394a90a82a63
198211simvastatin 40 MG Oral TabletPSNf835af8f-7d84-1978-e053-6294a90a22ae3
198211simvastatin 40 MG Oral TabletPSNf5dd1835-6d40-40da-e053-2a95a90ad1213
198211simvastatin 40 MG Oral TabletSCDf94d5907-737e-df67-e053-6394a90a82a63
198211simvastatin 40 MG Oral TabletSCDf835af8f-7d84-1978-e053-6294a90a22ae3
198211simvastatin 40 MG Oral TabletSCDf5dd1835-6d40-40da-e053-2a95a90ad1213
198211simvastatin 40 MG Oral TabletPSN06703194-b41a-2bbe-e063-6394a90ac41f2
198211simvastatin 40 MG Oral TabletSCD06703194-b41a-2bbe-e063-6394a90ac41f2
198211simvastatin 40 MG Oral TabletPSNf2f67ab8-49a1-23df-e053-2a95a90a40501
198211simvastatin 40 MG Oral TabletPSNadf42271-76c0-0fd2-e053-2995a90af7eb1
198211simvastatin 40 MG Oral TabletPSN52573b98-6e51-9753-e063-6294a90ac8c41
198211simvastatin 40 MG Oral TabletSCDf2f67ab8-49a1-23df-e053-2a95a90a40501
198211simvastatin 40 MG Oral TabletSCDadf42271-76c0-0fd2-e053-2995a90af7eb1
198211simvastatin 40 MG Oral TabletSCD52573b98-6e51-9753-e063-6294a90ac8c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-464-03681800464031000 TABLET, FILM COATED in 1 BOTTLE (68180-464-03) 2016-02-190000-00-00NoNoCurrent
68180-464-066818004640630 TABLET, FILM COATED in 1 BOTTLE (68180-464-06) 2016-07-290000-00-00NoNoCurrent
68180-464-096818004640990 TABLET, FILM COATED in 1 BOTTLE (68180-464-09) 2016-04-060000-00-00NoNoCurrent