FDA.reportPublic FDA data

Celecoxib

Product NDC
60505-3848
11-digit product format
605053848
Labeler code
60505
Product ID
60505-3848_3f02b96b-79f0-71a0-fd31-ab495401b187
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA204197
Marketing category
ANDA
Marketing start
2015-06-03
Marketing end
2027-03-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 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
60505-3848-1Celecoxib100 in 1 BOTTLECAPSULE10025
60505-3848-3Celecoxib30 in 1 BOTTLECAPSULE3025
60505-3848-5Celecoxib500 in 1 BOTTLECAPSULE50025
60505-3848-8Celecoxib1000 in 1 BOTTLECAPSULE100025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3848-1EA - Each60505-384899475c00-2f20-4f21-8c7f-877cbb0fd9ac12015-07-20
60505-3848-5EA - Each60505-3848eb0ea48c-60b4-47e7-923f-b26ff33360c712015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CelecoxibACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [APOTEX CORP.]11
CelecoxibACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [APOTEX CORP.]11
ALCOHOLINACTIVE INGREDIENT3K9958V90MCELECOXIB CAPSULE [APOTEX CORP.]11
AMMONIAINACTIVE INGREDIENT5138Q19F1XCELECOXIB CAPSULE [APOTEX CORP.]11
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CELECOXIB CAPSULE [APOTEX CORP.]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCELECOXIB CAPSULE [APOTEX CORP.]11
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCELECOXIB CAPSULE [APOTEX CORP.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCELECOXIB CAPSULE [APOTEX CORP.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACELECOXIB CAPSULE [APOTEX CORP.]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCELECOXIB CAPSULE [APOTEX CORP.]11
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [APOTEX CORP.]11
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CELECOXIB CAPSULE [APOTEX CORP.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [APOTEX CORP.]11
POVIDONEINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [APOTEX CORP.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [APOTEX CORP.]11
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [APOTEX CORP.]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICELECOXIB CAPSULE [APOTEX CORP.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [APOTEX CORP.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [APOTEX CORP.]11
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
POVIDONE K12INACTIVE INGREDIENT333AG72FWJCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3848CELECOXIB CAPSULE [APOTEX CORP.]24Current NDC, Legacy NDC, 4 package rows20250302_a62612b3-9564-2b34-be59-6aa5ac53679c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNa62612b3-9564-2b34-be59-6aa5ac53679c25
205323celecoxib 200 MG Oral CapsulePSNa62612b3-9564-2b34-be59-6aa5ac53679c25
686379celecoxib 50 MG Oral CapsulePSNa62612b3-9564-2b34-be59-6aa5ac53679c25
205322celecoxib 100 MG Oral CapsuleSCDa62612b3-9564-2b34-be59-6aa5ac53679c25
205323celecoxib 200 MG Oral CapsuleSCDa62612b3-9564-2b34-be59-6aa5ac53679c25
686379celecoxib 50 MG Oral CapsuleSCDa62612b3-9564-2b34-be59-6aa5ac53679c25
205322celecoxib 100 MG Oral CapsulePSNd94849a7-1831-4319-982c-c6b20dc4203810
205322celecoxib 100 MG Oral CapsuleSCDd94849a7-1831-4319-982c-c6b20dc4203810
205322celecoxib 100 MG Oral CapsulePSN370b2bb0-8fb7-4e42-8ec4-e14bae2c4a469
205323celecoxib 200 MG Oral CapsulePSN370b2bb0-8fb7-4e42-8ec4-e14bae2c4a469
205322celecoxib 100 MG Oral CapsuleSCD370b2bb0-8fb7-4e42-8ec4-e14bae2c4a469
205323celecoxib 200 MG Oral CapsuleSCD370b2bb0-8fb7-4e42-8ec4-e14bae2c4a469
205322celecoxib 100 MG Oral CapsulePSN8e8820f6-254c-67f4-e053-2995a90aee791
205322celecoxib 100 MG Oral CapsuleSCD8e8820f6-254c-67f4-e053-2995a90aee791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3848-160505384801100 CAPSULE in 1 BOTTLE (60505-3848-1) 100 capsule2015-06-032027-03-31NoNoCurrent
60505-3848-36050538480330 CAPSULE in 1 BOTTLE (60505-3848-3) 30 capsule2015-06-030000-00-00NoNoCurrent
60505-3848-560505384805500 CAPSULE in 1 BOTTLE (60505-3848-5) 500 capsule2015-06-030000-00-00NoNoCurrent
60505-3848-8605053848081000 CAPSULE in 1 BOTTLE (60505-3848-8) 1000 capsule2015-06-030000-00-00NoNoCurrent