FDA.reportPublic FDA data

Celecoxib

Product NDC
43063-825
11-digit product format
430630825
Labeler code
43063
Product ID
43063-825_525a2fed-c3a3-d498-e063-6394a90a7591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA204197
Marketing category
ANDA
Marketing start
2015-06-03
Marketing end
2027-05-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib

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
43063-825-10Celecoxib10 in 1 BOTTLE, PLASTICCAPSULE1032
43063-825-14Celecoxib14 in 1 BOTTLE, PLASTICCAPSULE1432
43063-825-30Celecoxib30 in 1 BOTTLE, PLASTICCAPSULE3032
43063-825-60Celecoxib60 in 1 BOTTLE, PLASTICCAPSULE6032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-825-10EA - Each43063-825e8c36716-7afd-44db-9042-ed2f3111b6af12018-02-20
43063-825-14EA - Each43063-825674aa56a-76e3-4619-aa2d-daf14b06212b12018-02-20
43063-825-30EA - Each43063-825342a3855-6e2d-4539-b693-3a1fc25e68f712018-02-20
43063-825-60EA - Each43063-8251fede085-3b8a-4776-bbd3-24ab0ab37bab12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-825CELECOXIB CAPSULE [PD-RX PHARMACEUTICALS, INC.]30Current NDC, Legacy NDC, 4 package rows20250309_52572bfb-43f0-4b55-b1fd-231a05c8b83e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN52572bfb-43f0-4b55-b1fd-231a05c8b83e32
205323celecoxib 200 MG Oral CapsuleSCD52572bfb-43f0-4b55-b1fd-231a05c8b83e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-825-104306308251010 CAPSULE in 1 BOTTLE, PLASTIC (43063-825-10) 10 capsule2018-01-242027-05-31NoNoCurrent
43063-825-144306308251414 CAPSULE in 1 BOTTLE, PLASTIC (43063-825-14) 14 capsule2018-01-232027-05-31NoNoCurrent
43063-825-304306308253030 CAPSULE in 1 BOTTLE, PLASTIC (43063-825-30) 30 capsule2018-01-122027-05-31NoNoCurrent
43063-825-604306308256060 CAPSULE in 1 BOTTLE, PLASTIC (43063-825-60) 60 capsule2018-02-282027-05-31NoNoCurrent