FDA.reportPublic FDA data

Pro-C-Dure 6 Kit

Product NDC
76420-622
Requested package NDC
76420-622-01
11-digit product format
764200622
Labeler code
76420
Product ID
76420-622_07064ca3-dc6a-0927-e063-6294a90aac46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
kenalog
Dosage form
KIT
Route
INTRA-ARTICULAR; INTRAMUSCULAR
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-08-17
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Pro-C-Dure 6 Kit
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1792144Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c627313-948f-4867-b64a-8e9adc40c405Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1049-2Pro-C-Dure 6 Kit1 mL in 1 VIALINJECTION, SUSPENSION3 mL40 mg in 1mL1
70121-1049-2Pro-C-Dure 6 Kit1 in 1 CARTONINJECTION, SUSPENSION40 mg in 1mL1
76420-622-01Pro-C-Dure 6 Kit1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-622PRO-C-DURE 6 KIT (KENALOG) KIT [ASCLEMED USA, INC.]1Current NDC, 3 package rows20231006_3c627313-948f-4867-b64a-8e9adc40c405.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pro-C-Dure 6 KitKENALOGAsclemed USA, Inc.3c627313-948f-4867-b64a-8e9adc40c4052023-10-06Warnings, Adverse reactionsExact identifier
ndc (package): 76420-622-01
ndc (product): 76420-622
ndc11 (package): 76420062201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN3c627313-948f-4867-b64a-8e9adc40c4051
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD3c627313-948f-4867-b64a-8e9adc40c4051
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY3c627313-948f-4867-b64a-8e9adc40c4051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-622-01764200622011 KIT in 1 CARTON (76420-622-01) * 1 VIAL in 1 CARTON (70121-1049-2) / 1 mL in 1 VIAL1 kit2023-10-04NoNoCurrent