Silka

Product NDC
51769-121
11-digit product format
517690121
Labeler code
51769
Product ID
51769-121_b9d1bef7-4b9d-f2c9-e053-2995a90ae9ac
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
All Natural Dynamics
Application
ANDA077511
Marketing category
ANDA
Marketing start
2021-01-18
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
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
51769-121-302024-12-30C16284748780-1f386c649-c854-0266-e053-dadaa90a7c1ab9d1bef7-4b9c-f2c9-e053-2995a90ae9ac
51769-121-302023-01-30C16284748780-1f386c649-c854-0266-e053-dadaa90a7c1ab9d1bef7-4b9c-f2c9-e053-2995a90ae9ac

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51769-121-305176901213030 g in 1 TUBE (51769-121-30) 30 g2021-01-180000-00-00NoNoCurrent