Amcinonide

Product NDC
0168-0279
11-digit product format
001680279
Labeler code
0168
Product ID
0168-0279_dda607c9-29ec-40bd-a925-cb74036f4790
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amcinonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA076096
Marketing category
ANDA
Marketing start
2014-04-03
Marketing end
0000-00-00
Substance
AMCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0fb13bea-60d5-d576-4a84-8309e25165c0Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c0873041-d18b-ad0e-0adf-75965d870ba7Product name120140508
c8da84f8-c4bb-d0f3-daba-c86a13a1d1c9Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0279-602020-01-31C16284748780-19d75b9d0-4f72-f424-e053-dadaa90a57ceAMCINONIDE OINTMENT USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0279-60Amcinonide60 g in 1 TUBEOINTMENT604
0168-0279-60Amcinonide1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0279-60GM - Gram0168-02790251d804-b54a-4851-9bee-aefdbbb7161912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0279AMCINONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4Legacy NDC, 2 package rows20140408_3a386f5e-530d-446b-a0fb-6b9a667ad23f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197328amcinonide 0.1 % Topical OintmentPSN3a386f5e-530d-446b-a0fb-6b9a667ad23f4
197328amcinonide 0.001 MG/MG Topical OintmentSCD3a386f5e-530d-446b-a0fb-6b9a667ad23f4
197328amcinonide 0.1 % Topical OintmentSY3a386f5e-530d-446b-a0fb-6b9a667ad23f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0168-0279-600016802796060 g in 1 TUBE60 gHistorical