FDA.reportPublic FDA data

Veregen

Product NDC
62559-385
11-digit product format
625590385
Labeler code
62559
Product ID
62559-385_64ad4fa5-8381-41db-8d9b-62fa44843180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sinecatechins
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA021902
Marketing category
NDA
Marketing start
2022-11-10
Substance
SINECATECHINS
Active strength
150 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Veregen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SINECATECHINS150 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT432289GYZ
Rxcui753350, 795918

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2a7517d6-bad6-4df6-d01f-72b4e8293572Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-385-02Veregen1 in 1 CARTONOINTMENT11
62559-385-02Veregen2 g in 1 TUBEOINTMENT21
62559-385-26Veregen6 in 1 CARTONOINTMENT61
62559-385-30Veregen30 g in 1 TUBEOINTMENT301
62559-385-30Veregen1 in 1 CARTONOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-385-30GM - Gram62559-385fc0bed4a-4f04-4e65-a64a-97bd3bf5dd9212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-385VEREGEN (SINECATECHINS) OINTMENT [ANI PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 5 package rows20221115_f0fc1e21-e3cf-4bce-860c-307f670b192e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753350sinecatechins 15 % Topical OintmentPSNf0fc1e21-e3cf-4bce-860c-307f670b192e1
795918VEREGEN 15 % Topical OintmentPSNf0fc1e21-e3cf-4bce-860c-307f670b192e1
795918sinecatechins 0.15 MG/MG Topical Ointment [Veregen]SBDf0fc1e21-e3cf-4bce-860c-307f670b192e1
753350sinecatechins 0.15 MG/MG Topical OintmentSCDf0fc1e21-e3cf-4bce-860c-307f670b192e1
753350sinecatechins 15 % Topical OintmentSYf0fc1e21-e3cf-4bce-860c-307f670b192e1
795918Veregen 0.15 MG/MG Topical OintmentSYf0fc1e21-e3cf-4bce-860c-307f670b192e1
795918Veregen 15 % Topical OintmentSYf0fc1e21-e3cf-4bce-860c-307f670b192e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-385-02625590385021 in 1 CARTONHistorical
62559-385-26625590385266 CARTON in 1 CARTON (62559-385-26) / 1 TUBE in 1 CARTON (62559-385-02) / 2 g in 1 TUBE6 carton2022-11-100000-00-00YesNoCurrent
62559-385-30625590385301 TUBE in 1 CARTON (62559-385-30) / 30 g in 1 TUBE1 tube2022-11-100000-00-00NoNoCurrent