FDA.reportPublic FDA data

Pro-C-Dure 5 Kit

Product NDC
69263-820
Requested package NDC
69263-820-01
11-digit product format
692630820
Labeler code
69263
Product ID
69263-820_cb25cc40-913f-404b-e053-2a95a90a86b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
kenalog
Dosage form
KIT
Route
INTRA-ARTICULAR; INTRAMUSCULAR
Labeler
Oaklock, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-10-04
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69263-82069263-820-01DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69263-82069263-820-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69263-82069263-820-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-12-12Pro-C-Dure 5 Kit
2023-01-30Pro-C-Dure 5 Kit
2020-03-11Pro-C-Dure 5 Kit
2020-01-31Pro-C-Dure 5 Kit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69263-820-01EA - Each69263-82026563d64-7fda-448c-b03a-703fb5506f3112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KAPRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KAPRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1
NITROGENINACTIVE INGREDIENTN762921K75PRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69263-820PRO-C-DURE 5 KIT (KENALOG) KIT [OAKLOCK, LLC]8Legacy NDC20241019_68fc4863-595a-48f2-809b-98425d9607f4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69263-820-01692630820011 KIT in 1 CARTON (69263-820-01) * 1 VIAL in 1 CARTON (70121-1049-2) > 1 mL in 1 VIAL1 kit2021-10-040000-00-00NoNoCurrent