FDA.reportPublic FDA data

SULINDAC

Product NDC
42806-011
11-digit product format
428060011
Labeler code
42806
Product ID
42806-011_fb793a0a-affa-4f9a-a5b4-aa1c84aa475e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULINDAC
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA072711
Marketing category
ANDA
Marketing start
2010-01-25
Substance
SULINDAC
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULINDAC200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii184SNS8VUH
Rxcui198238, 198239

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c7c8244c-3606-b814-8453-06ab13fc5907Product name220201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-011-01SULINDAC100 in 1 BOTTLETABLET10019
42806-011-05SULINDAC500 in 1 BOTTLETABLET50019
42806-011-10SULINDAC1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-011-01EA - Each42806-011b40d39e6-3659-4a83-9c18-6a63b70d49f312012-07-24
42806-011-05EA - Each42806-011fc2507a4-3187-4502-9037-c854493fd0f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULINDACACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [EPIC PHARMA, LLC]9
SULINDACACTIVE MOIETY184SNS8VUHSULINDAC TABLET [EPIC PHARMA, LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULINDAC TABLET [EPIC PHARMA, LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULINDAC TABLET [EPIC PHARMA, LLC]9
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQSULINDAC TABLET [EPIC PHARMA, LLC]9
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSULINDAC TABLET [EPIC PHARMA, LLC]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULINDAC TABLET [EPIC PHARMA, LLC]9
SULINDACACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [AIDAREX PHARMACEUTICALS LLC]1
SULINDACACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SULINDACACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [STAT RX USA LLC]1
SULINDACACTIVE MOIETY184SNS8VUHSULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SULINDACACTIVE MOIETY184SNS8VUHSULINDAC TABLET [AIDAREX PHARMACEUTICALS LLC]1
SULINDACACTIVE MOIETY184SNS8VUHSULINDAC TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULINDAC TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULINDAC TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULINDAC TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULINDAC TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSULINDAC TABLET [STAT RX USA LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSULINDAC TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULINDAC TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULINDAC TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-011SULINDAC TABLET [EPIC PHARMA, LLC]19Current NDC, Legacy NDC, 3 package rows20241222_96c73bd2-4577-487d-a642-bd8f91e94c3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198238sulindac 150 MG Oral TabletPSN96c73bd2-4577-487d-a642-bd8f91e94c3a19
198239sulindac 200 MG Oral TabletPSN96c73bd2-4577-487d-a642-bd8f91e94c3a19
198238sulindac 150 MG Oral TabletSCD96c73bd2-4577-487d-a642-bd8f91e94c3a19
198239sulindac 200 MG Oral TabletSCD96c73bd2-4577-487d-a642-bd8f91e94c3a19
198239sulindac 200 MG Oral TabletPSN6041acc2-5e8a-4d3c-bf50-7e9447748e2b16
198239sulindac 200 MG Oral TabletSCD6041acc2-5e8a-4d3c-bf50-7e9447748e2b16
198239sulindac 200 MG Oral TabletPSN7a0afa8a-9660-453b-a47d-29c20a8d2d6b1
198239sulindac 200 MG Oral TabletPSNc17e8534-4e71-4166-a4fc-9df6cf6dd49b1
198239sulindac 200 MG Oral TabletPSNd94e8865-d151-4fb1-bacd-f4e43819e3c21
198239sulindac 200 MG Oral TabletPSNdf5f89a8-70b3-40bc-8a05-8daa8c881d061
198239sulindac 200 MG Oral TabletSCD7a0afa8a-9660-453b-a47d-29c20a8d2d6b1
198239sulindac 200 MG Oral TabletSCDc17e8534-4e71-4166-a4fc-9df6cf6dd49b1
198239sulindac 200 MG Oral TabletSCDd94e8865-d151-4fb1-bacd-f4e43819e3c21
198239sulindac 200 MG Oral TabletSCDdf5f89a8-70b3-40bc-8a05-8daa8c881d061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-011-0142806001101100 TABLET in 1 BOTTLE (42806-011-01) 100 tablet2010-01-250000-00-00NoNoCurrent
42806-011-0542806001105500 TABLET in 1 BOTTLE (42806-011-05) 500 tablet2010-01-250000-00-00NoNoCurrent
42806-011-10428060011101000 TABLET in 1 BOTTLE (42806-011-10) 1000 tablet2010-01-250000-00-00NoNoCurrent