Celecoxib

Product NDC
63187-562
11-digit product format
631870562
Labeler code
63187
Product ID
63187-562_94327867-b615-4077-85a8-b7647355169b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204197
Marketing category
ANDA
Marketing start
2015-06-03
Substance
CELECOXIB
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
Celecoxib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205323

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
63187-562-15Celecoxib15 in 1 BOTTLECAPSULE153
63187-562-30Celecoxib30 in 1 BOTTLECAPSULE303
63187-562-60Celecoxib60 in 1 BOTTLECAPSULE603
63187-562-90Celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-562-30EA - Each63187-56260b2800d-e469-42df-acea-44a70868fd0912016-04-04
63187-562-60EA - Each63187-5620f28a743-fb25-4390-9a3c-5a62475d36cb12016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CelecoxibACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [PROFICIENT RX LP]1
CelecoxibACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [PROFICIENT RX LP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCELECOXIB CAPSULE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XCELECOXIB CAPSULE [PROFICIENT RX LP]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CELECOXIB CAPSULE [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCELECOXIB CAPSULE [PROFICIENT RX LP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCELECOXIB CAPSULE [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCELECOXIB CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [PROFICIENT RX LP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CELECOXIB CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-562CELECOXIB CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20210113_6dd743d3-4821-4919-90eb-6d306ca7999f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN6dd743d3-4821-4919-90eb-6d306ca7999f3
205323celecoxib 200 MG Oral CapsuleSCD6dd743d3-4821-4919-90eb-6d306ca7999f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-562-156318705621515 CAPSULE in 1 BOTTLE (63187-562-15) 15 capsule2018-12-010000-00-00NoNoCurrent
63187-562-306318705623030 CAPSULE in 1 BOTTLE (63187-562-30) 30 capsule2018-12-010000-00-00NoNoCurrent
63187-562-606318705626060 CAPSULE in 1 BOTTLE (63187-562-60) 60 capsule2018-12-010000-00-00NoNoCurrent
63187-562-906318705629090 CAPSULE in 1 BOTTLE (63187-562-90) 90 capsule2018-12-010000-00-00NoNoCurrent