Synalar

Product NDC
43538-920
11-digit product format
435380920
Labeler code
43538
Product ID
43538-920_25a47959-6d92-4ec7-a25e-0dab6d1d2b16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
NDA015296
Marketing category
NDA
Marketing start
2012-05-31
Marketing end
0000-00-00
Substance
FLUOCINOLONE ACETONIDE
Active strength
0 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43538-920-602023-10-26C16284748780-1c7ccaba7-2493-fd44-e053-dadaa90aa01b4feecef4-553f-4a90-a3ce-a19eb04bd68e
43538-920-602023-07-28C16284748780-1c7ccaba7-2493-fd44-e053-dadaa90aa01b4feecef4-553f-4a90-a3ce-a19eb04bd68e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-920-60ML - Milliliter43538-920517a5ce6-e6d2-466d-9b23-d03af7d95ef812013-02-13
43538-920-90ML - Milliliter43538-9207c181df9-f5e6-4091-a6c0-4881ce65d6fc12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43538-920-60435380920601 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-60) > 60 mL in 1 BOTTLE, WITH APPLICATOR2012-05-310000-00-00NoNoCurrent
43538-920-90435380920901 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-90) > 90 mL in 1 BOTTLE, WITH APPLICATOR2012-08-150000-00-00NoNoCurrent
43538-920-99435380920991 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-99) > 13 mL in 1 BOTTLE, WITH APPLICATOR2012-08-150000-00-00NoNoCurrent