FDA.reportPublic FDA data

Celecoxib

Product NDC
68788-8206
11-digit product format
687888206
Labeler code
68788
Product ID
68788-8206_7f0e6285-dbbf-4999-9635-acea0bd040f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA205129
Marketing category
ANDA
Marketing start
2023-01-02
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
Listing certified through
2027-12-31
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
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322

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
68788-8206-3Celecoxib30 in 1 BOTTLECAPSULE304
68788-8206-6Celecoxib100 in 1 BOTTLECAPSULE1004
68788-8206-9Celecoxib500 in 1 BOTTLECAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8206-3EA - Each68788-8206f2eb48e1-c70d-46d8-97ca-eed4f527365412023-06-06
68788-8206-6EA - Each68788-82063424a0a4-a3a7-4d85-aba2-641557bf494812023-06-06
68788-8206-9EA - Each68788-8206901585ee-8039-4319-9b20-c76de7fd2d3712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8206CELECOXIB CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, 3 package rows20250221_d35d9494-4190-41a8-80d4-c9d877c432e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNd35d9494-4190-41a8-80d4-c9d877c432e94
205322celecoxib 100 MG Oral CapsuleSCDd35d9494-4190-41a8-80d4-c9d877c432e94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8206-36878882060330 CAPSULE in 1 BOTTLE (68788-8206-3) 30 capsule2023-01-02NoNoHistorical
68788-8206-668788820606100 CAPSULE in 1 BOTTLE (68788-8206-6) 100 capsule2023-01-02NoNoHistorical
68788-8206-968788820609500 CAPSULE in 1 BOTTLE (68788-8206-9) 500 capsule2023-01-02NoNoHistorical