Fluocinonide

Product NDC
69238-1271
11-digit product format
692381271
Labeler code
69238
Product ID
69238-1271_3f44c60e-c3a6-468c-92ba-f423cbd3fa06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211111
Marketing category
ANDA
Marketing start
2018-07-31
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1271-2GM - Gram69238-1271b5c39173-09af-4fd4-9b00-51e6f6d41bda12018-11-06
69238-1271-3GM - Gram69238-12715b697eee-a300-4a8c-ac6b-5ecc053064bd12018-11-06
69238-1271-6GM - Gram69238-1271641e0ea7-1adc-4437-bddf-870feb33053212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1271FLUOCINONIDE CREAM [AMNEAL PHARMACEUTICALS NY LLC]8Legacy NDC20231231_41584f59-b641-4494-8b8e-7c845ac47335.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSNb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 1 MG/ML Topical CreamSCDb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 0.1 % Topical CreamSYb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 1 MG per 1 GM Topical CreamSYb387f926-1109-41b2-9fe0-f77db6b102801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1271-2692381271021 TUBE in 1 CARTON (69238-1271-2) > 120 g in 1 TUBE1 tube2018-07-310000-00-00NoNoCurrent
69238-1271-3692381271031 TUBE in 1 CARTON (69238-1271-3) > 30 g in 1 TUBE1 tube2018-07-310000-00-00NoNoCurrent
69238-1271-6692381271061 TUBE in 1 CARTON (69238-1271-6) > 60 g in 1 TUBE1 tube2018-07-310000-00-00NoNoCurrent