FLUTAMIDE

Product NDC
69097-915
11-digit product format
690970915
Labeler code
69097
Product ID
69097-915_b002fcb1-d247-4333-b38a-6b1de5a05a2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUTAMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA075780
Marketing category
ANDA
Marketing start
2016-09-21
Marketing end
0000-00-00
Substance
FLUTAMIDE
Active strength
125 mg/1
Pharmacologic classes
Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-915-91EA - Each69097-915503be284-76bb-494a-9f11-2034ede1949d12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-915FLUTAMIDE CAPSULE [CIPLA USA INC.]2Legacy NDC20181129_328910be-4d0e-4d7b-a062-e3ce0cf793b9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-915-1269097091512500 CAPSULE in 1 BOTTLE (69097-915-12) 500 capsule2016-09-210000-00-00NoNoCurrent
69097-915-9169097091591180 CAPSULE in 1 BOTTLE (69097-915-91) 180 capsule2016-09-210000-00-00NoNoCurrent