Ketoprofen

Product NDC
85477-111
11-digit product format
854770111
Labeler code
85477
Product ID
85477-111_0b2637a6-551b-4be3-8d1a-dad8fbf764b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Oncora Pharma, LLC
Application
ANDA074014
Marketing category
ANDA
Marketing start
2026-03-01
Substance
KETOPROFEN
Active strength
50 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
Ketoprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOPROFEN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii90Y4QC304K
Rxcui197855

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
460c0bb5-c2b5-c96e-0f79-68a0385a39a0Product name220201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-111-01Ketoprofen100 in 1 BOTTLECAPSULE1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197855ketoprofen 50 MG Oral CapsulePSN492de5dc-7c1b-47be-8510-43be4e1fd4ed2
197855ketoprofen 50 MG Oral CapsuleSCD492de5dc-7c1b-47be-8510-43be4e1fd4ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-111-0185477011101100 CAPSULE in 1 BOTTLE (85477-111-01) 100 capsule2026-03-01NoNoCurrent