Fluoroplex

Product NDC
16110-812
11-digit product format
161100812
Labeler code
16110
Product ID
16110-812_0d7ce07c-d2a5-4d78-adb9-c7196c6cb3a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluorouracil
Dosage form
CREAM
Route
TOPICAL
Labeler
Almirall, LLC
Application
NDA016988
Marketing category
NDA
Marketing start
1993-12-03
Marketing end
0000-00-00
Substance
FLUOROURACIL
Active strength
10 mg/g
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16110-812-302025-11-13C16284748780-11030e364-fb48-111a-e063-dadaa90a10e2258bb79a-56b3-4f46-ade6-7331ec031074
16110-812-302024-01-30C16284748780-11030e364-fb48-111a-e063-dadaa90a10e2258bb79a-56b3-4f46-ade6-7331ec031074

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16110-812-30GM - Gram16110-812da8b9fcc-7cd2-4c4a-8348-59906f645ee112013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16110-812FLUOROPLEX (FLUOROURACIL) CREAM [ALMIRALL, LLC]9Legacy NDC20220318_258bb79a-56b3-4f46-ade6-7331ec031074.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16110-812-30161100812301 TUBE in 1 CARTON (16110-812-30) > 30 g in 1 TUBE1 tube1993-12-030000-00-00NoNoCurrent