TERBINAFINE HYDROCHLORIDE

Product NDC
70518-3085
11-digit product format
705183085
Labeler code
70518
Product ID
70518-3085_c1969889-3baa-c684-e053-2a95a90a5412
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Tablets 250 mg
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077137
Marketing category
ANDA
Marketing start
2021-05-05
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
70518-3085-02023-03-16C16284748780-1f386c64a-158b-0266-e053-dadaa90a7c1a88b892cc-a991-4ceb-83c3-cb9c958e5f8a
70518-3085-02023-01-30C16284748780-1f386c64a-158b-0266-e053-dadaa90a7c1a88b892cc-a991-4ceb-83c3-cb9c958e5f8a

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3085-07051830850030 TABLET in 1 BLISTER PACK (70518-3085-0) 30 tablet2021-05-050000-00-00NoNoCurrent