Terbinafine Hydrochloride

Product NDC
70518-1743
11-digit product format
705181743
Labeler code
70518
Product ID
70518-1743_c4407ed9-0672-0ba9-e053-2995a90a3883
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077714
Marketing category
ANDA
Marketing start
2018-12-18
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
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
70518-1743-02023-03-06C16284748780-1f386c64a-18c8-0266-e053-dadaa90a7c1a0be26591-e0dd-429d-a4c7-b2e39aab13dd
70518-1743-02023-01-30C16284748780-1f386c64a-18c8-0266-e053-dadaa90a7c1a0be26591-e0dd-429d-a4c7-b2e39aab13dd

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1743-07051817430030 TABLET in 1 BLISTER PACK (70518-1743-0) 30 tablet2018-12-180000-00-00NoNoCurrent