Olanzapine

Product NDC
70518-3189
11-digit product format
705183189
Labeler code
70518
Product ID
70518-3189_c9489190-400e-2c86-e053-2995a90aeffa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204319
Marketing category
ANDA
Marketing start
2021-08-10
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [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
70518-3189-02023-03-21C16284748780-1f386c64a-02b8-0266-e053-dadaa90a7c1a065ca06f-fa4b-4823-9672-113a05508265
70518-3189-02023-01-30C16284748780-1f386c64a-02b8-0266-e053-dadaa90a7c1a065ca06f-fa4b-4823-9672-113a05508265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3189-07051831890030 TABLET in 1 BLISTER PACK (70518-3189-0) 30 tablet2021-08-100000-00-00NoNoCurrent