FDA.reportPublic FDA data

Celecoxib

Product NDC
82804-213
11-digit product format
828040213
Labeler code
82804
Product ID
82804-213_2708ae7f-53a6-478d-bf2e-e4f43e6bb323
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210071
Marketing category
ANDA
Marketing start
2020-12-21
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
82804-213-14Celecoxib14 in 1 BOTTLECAPSULE144
82804-213-30Celecoxib30 in 1 BOTTLECAPSULE304
82804-213-60Celecoxib60 in 1 BOTTLECAPSULE604
82804-213-90Celecoxib90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-213-14EA - Each82804-2137d4cdc9e-fafe-45d9-872b-1ceadc1932a312025-11-13
82804-213-30EA - Each82804-21328ee83e3-f5fc-450b-bad4-a093e2ee96a712025-06-13
82804-213-60EA - Each82804-213b1abb67a-509e-4550-996a-bbb4b20b80c812025-06-13
82804-213-90EA - Each82804-2130c883021-5031-4b7e-8a74-04fefc69569612025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-213CELECOXIB CAPSULE [PROFICIENT RX LP]3Current NDC, 4 package rows20250504_3a450db8-313c-4120-9b8e-58c956323fa4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN3a450db8-313c-4120-9b8e-58c956323fa44
205323celecoxib 200 MG Oral CapsuleSCD3a450db8-313c-4120-9b8e-58c956323fa44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-213-148280402131414 CAPSULE in 1 BOTTLE (82804-213-14) 14 capsule2025-06-26NoNoCurrent
82804-213-308280402133030 CAPSULE in 1 BOTTLE (82804-213-30) 30 capsule2025-04-03NoNoCurrent
82804-213-608280402136060 CAPSULE in 1 BOTTLE (82804-213-60) 60 capsule2025-04-21NoNoCurrent
82804-213-908280402139090 CAPSULE in 1 BOTTLE (82804-213-90) 90 capsule2025-05-02NoNoCurrent