Granisetron Hydrochloride

Product NDC
42043-390
11-digit product format
420430390
Labeler code
42043
Product ID
42043-390_d3bd51f3-d9f9-462c-bd71-a8c8627bd54d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Granisetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
OrchidPharma Inc
Application
ANDA078678
Marketing category
ANDA
Marketing start
2016-04-12
Marketing end
0000-00-00
Substance
GRANISETRON HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
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
42043-390-00EA - Each42043-390d570196f-b1e1-4e50-a0ca-34bd6768cc2a12016-06-14
42043-390-02EA - Each42043-390b84db839-f972-4af9-bb36-167222e7269e12016-05-16
42043-390-20EA - Each42043-39006ef7fd2-9381-46e9-a7f7-7dff7a674f1b12016-05-16
42043-390-21EA - Each42043-390112cf5a3-47e2-41f6-9a22-9ab1174bec6312016-05-16
42043-390-40EA - Each42043-39008d6139d-dce7-407c-9250-e0f257f605cc12016-06-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42043-390-02420430390022 BLISTER PACK in 1 CARTON (42043-390-02) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42043-390-00) 2 blister pack2016-04-120000-00-00NoNoCurrent
42043-390-204204303902020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42043-390-20) 2016-04-120000-00-00NoNoCurrent
42043-390-21420430390212 BLISTER PACK in 1 CARTON (42043-390-21) > 10 TABLET, FILM COATED in 1 BLISTER PACK (42043-390-40) 2 blister pack2016-04-120000-00-00NoNoCurrent