FDA.reportPublic FDA data

celecoxib

Product NDC
68180-396
11-digit product format
681800396
Labeler code
68180
Product ID
68180-396_c7509f8b-4cac-4294-8e22-0e954c75f793
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA202240
Marketing category
ANDA
Marketing start
2015-08-07
Substance
CELECOXIB
Active strength
100 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
celecoxib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 349514, 686379

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-396-01celecoxib100 in 1 BOTTLECAPSULE10015
68180-396-02celecoxib500 in 1 BOTTLECAPSULE50015
68180-396-03celecoxib1000 in 1 BOTTLECAPSULE100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-396-01EA - Each68180-396ca205dda-ac35-4a29-ad97-45a595cad53812016-05-16
68180-396-02EA - Each68180-39630a6ff87-8244-4022-9b55-37e4fd66b0bd12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-396CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 3 package rows20231209_560017b1-daf8-464e-b86f-0a75c78002ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN560017b1-daf8-464e-b86f-0a75c78002ec15
205323celecoxib 200 MG Oral CapsulePSN560017b1-daf8-464e-b86f-0a75c78002ec15
349514celecoxib 400 MG Oral CapsulePSN560017b1-daf8-464e-b86f-0a75c78002ec15
686379celecoxib 50 MG Oral CapsulePSN560017b1-daf8-464e-b86f-0a75c78002ec15
205322celecoxib 100 MG Oral CapsuleSCD560017b1-daf8-464e-b86f-0a75c78002ec15
205323celecoxib 200 MG Oral CapsuleSCD560017b1-daf8-464e-b86f-0a75c78002ec15
349514celecoxib 400 MG Oral CapsuleSCD560017b1-daf8-464e-b86f-0a75c78002ec15
686379celecoxib 50 MG Oral CapsuleSCD560017b1-daf8-464e-b86f-0a75c78002ec15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-396-0168180039601100 CAPSULE in 1 BOTTLE (68180-396-01) 100 capsule2016-04-050000-00-00NoNoCurrent
68180-396-0268180039602500 CAPSULE in 1 BOTTLE (68180-396-02) 500 capsule2015-10-150000-00-00NoNoCurrent
68180-396-03681800396031000 CAPSULE in 1 BOTTLE (68180-396-03) 1000 capsule2015-08-070000-00-00NoNoCurrent