FDA.reportPublic FDA data

Carprofen

Manufacturer
COSMA Spa
Effective date
2023-11-06
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
3
Source
full-release
Hydrated at
2026-06-01 02:50:55

Label at a glance#

ProductCarprofen
Active ingredientCARPROFEN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COSMA S.P.A.  24040 CISERANO (BG) Italy Via Colleoni, 15/17

                      Telefono: 035.88.30.55 - Fax: 035.482.05.01

Product code: 1013         Drum Nr. 0/4

NDC n: 51604-0019-0

Batch:

CAUTION: "for manufacturing, processing, or repacking" "Rx only" Toxic solid, organic, no.o.s (carbazole, UN 2811

CAS 53716-49-7

Chemical name: 6-chloro-alpha-methyl-9H-carbazole-2-acetic acid

Man Date:      Retest Date:

Net Weight:   Gross Weight:

Store Conditions: Store below 30°C (86°F); excursions permitted to 40°C (104°F); Protect from light

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51604-0019-0Carprofen30 kg in 1 DRUMPOWDER303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51604-0019CARPROFEN POWDER [COSMA SPA]31 package rows20231115_5abd04b7-4a57-430d-9bb8-bc18cb7b237d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51604-001951604-0019-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARPROFENFFL0D546HOACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.