SERTRALINE HYDROCHLORIDE

Product NDC
50090-3945
11-digit product format
500903945
Labeler code
50090
Product ID
50090-3945_d7736b89-1ba0-498e-802d-703f700ac9f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3945-0EA - Each50090-394590988a9c-679c-46bc-8981-3ecd1b53396312021-12-08
50090-3945-1EA - Each50090-3945d9d9ac00-46a4-4fcb-ba8f-79739444134812021-12-08
50090-3945-2EA - Each50090-39450d818579-66d7-4924-964b-dee34a01b77912021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3945-05009039450030 TABLET, FILM COATED in 1 BOTTLE (50090-3945-0) 2018-12-100000-00-00NoNoCurrent
50090-3945-15009039450160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3945-1) 2017-02-090000-00-00NoNoCurrent
50090-3945-25009039450290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3945-2) 2017-02-090000-00-00NoNoCurrent