FDA.reportPublic FDA data

Celecoxib

Product NDC
60760-742
11-digit product format
607600742
Labeler code
60760
Product ID
60760-742_43d01230-86df-71a0-e063-6394a90ab293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
St Mary's Medical Park Pharmacy
Application
ANDA205129
Marketing category
ANDA
Marketing start
2022-05-27
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L

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
60760-742-15Celecoxib15 in 1 BOTTLE, PLASTICCAPSULE154
60760-742-30Celecoxib30 in 1 BOTTLE, PLASTICCAPSULE304
60760-742-60Celecoxib60 in 1 BOTTLE, PLASTICCAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-742-15EA - Each60760-742a08f8567-3516-442f-b40c-555ac206f35f12022-08-04
60760-742-30EA - Each60760-742e33d8d8a-b9fa-463b-b58f-a3880a6bd42212022-10-06
60760-742-60EA - Each60760-742802c0d19-8ddd-40b1-9499-2d286678caac12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-742CELECOXIB CAPSULE [ST MARY'S MEDICAL PARK PHARMACY]3Current NDC, Legacy NDC, 3 package rows20220819_e1ab644d-b668-3cf3-e053-2995a90addb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNe1ab644d-b668-3cf3-e053-2995a90addb04
205323celecoxib 200 MG Oral CapsuleSCDe1ab644d-b668-3cf3-e053-2995a90addb04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-742-156076007421515 CAPSULE in 1 BOTTLE, PLASTIC (60760-742-15) 15 capsule2022-05-270000-00-00NoNoCurrent
60760-742-306076007423030 CAPSULE in 1 BOTTLE, PLASTIC (60760-742-30) 30 capsule2022-08-090000-00-00NoNoCurrent
60760-742-606076007426060 CAPSULE in 1 BOTTLE, PLASTIC (60760-742-60) 60 capsule2022-06-170000-00-00NoNoCurrent