Ketoprofen

Product NDC
53217-221
11-digit product format
532170221
Labeler code
53217
Product ID
53217-221_f3f68719-f9c4-43dd-b16b-3f30b05fc190
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA073516
Marketing category
ANDA
Marketing start
1993-01-01
Marketing end
0000-00-00
Substance
KETOPROFEN
Active strength
50 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-221-30Ketoprofen30 in 1 BOTTLECAPSULE301
53217-221-45Ketoprofen45 in 1 BOTTLECAPSULE451
53217-221-60Ketoprofen60 in 1 BOTTLECAPSULE601
53217-221-90Ketoprofen90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-221-30EA - Each53217-2211e3b517f-53e5-4b8c-a604-301925c51ada12016-12-07
53217-221-45EA - Each53217-221ea407abd-6c13-4f40-99a7-693c0bdf266512016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-221KETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20161115_c8ba8fd5-e194-4d16-bdf0-e54577c60135.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197855ketoprofen 50 MG Oral CapsulePSNc8ba8fd5-e194-4d16-bdf0-e54577c601351
197855ketoprofen 50 MG Oral CapsuleSCDc8ba8fd5-e194-4d16-bdf0-e54577c601351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-221-305321702213030 in 1 BOTTLEHistorical
53217-221-455321702214545 in 1 BOTTLEHistorical
53217-221-605321702216060 in 1 BOTTLEHistorical
53217-221-905321702219090 in 1 BOTTLEHistorical