SULINDAC

Product NDC
24658-771
11-digit product format
246580771
Labeler code
24658
Product ID
24658-771_cb28dfa2-28af-47a2-ab7f-1c65720d9496
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULINDAC
Dosage form
TABLET
Route
ORAL
Labeler
PuraCap Laboratories LLC dba Blu Pharmaceuticals
Application
ANDA072711
Marketing category
ANDA
Marketing start
2016-11-14
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
24658-771-01SULINDAC100 in 1 BOTTLETABLET1009
24658-771-05SULINDAC500 in 1 BOTTLETABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-771-05EA - Each24658-7716f00eb99-0ea8-4037-93e4-2e532b22a47212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-771SULINDAC TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20231221_0feabf47-8d0d-48c0-b263-43db4969f39e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198238sulindac 150 MG Oral TabletPSN0feabf47-8d0d-48c0-b263-43db4969f39e9
198239sulindac 200 MG Oral TabletPSN0feabf47-8d0d-48c0-b263-43db4969f39e9
198238sulindac 150 MG Oral TabletSCD0feabf47-8d0d-48c0-b263-43db4969f39e9
198239sulindac 200 MG Oral TabletSCD0feabf47-8d0d-48c0-b263-43db4969f39e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24658-771-0124658077101100 TABLET in 1 BOTTLE (24658-771-01) 100 tablet2016-11-140000-00-00NoNoCurrent
24658-771-0524658077105500 TABLET in 1 BOTTLE (24658-771-05) 500 tablet2016-11-140000-00-00NoNoCurrent