FDA.reportPublic FDA data

celecoxib

Product NDC
43063-967
11-digit product format
430630967
Labeler code
43063
Product ID
43063-967_303a7843-3037-ba17-e063-6294a90ae0f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
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
43063-967-14celecoxib14 in 1 BOTTLE, PLASTICCAPSULE1415
43063-967-30celecoxib30 in 1 BOTTLE, PLASTICCAPSULE3015
43063-967-60celecoxib60 in 1 BOTTLE, PLASTICCAPSULE6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-967-14EA - Each43063-96782951afb-b184-4aaf-92d6-bb4e4f682e7e12020-07-13
43063-967-30EA - Each43063-967d18bf168-00d5-47ef-90a8-6d77f38efd1c12019-05-02
43063-967-60EA - Each43063-967ecf4f162-342b-44c0-9108-fdb8bead3eab12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-967CELECOXIB CAPSULE [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 3 package rows20250316_78d59905-4a78-4d9f-ac29-58790a5b3a92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN78d59905-4a78-4d9f-ac29-58790a5b3a9215
205323celecoxib 200 MG Oral CapsuleSCD78d59905-4a78-4d9f-ac29-58790a5b3a9215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-967-144306309671414 CAPSULE in 1 BOTTLE, PLASTIC (43063-967-14) 14 capsule2020-05-110000-00-00NoNoCurrent
43063-967-304306309673030 CAPSULE in 1 BOTTLE, PLASTIC (43063-967-30) 30 capsule2019-04-050000-00-00NoNoCurrent
43063-967-604306309676060 CAPSULE in 1 BOTTLE, PLASTIC (43063-967-60) 60 capsule2019-03-270000-00-00NoNoCurrent