DROSPIRENONE AND ETHINYL ESTRADIOL

Product NDC
0378-7299
11-digit product format
003787299
Labeler code
0378
Product ID
0378-7299_b912c765-1fd1-4b51-b3a1-7fdc12b69bfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
drospirenone and ethinyl estradiol
Dosage form
KIT
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202594
Marketing category
ANDA
Marketing start
2018-04-23
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7299-53EA - Each0378-729928344e8d-a991-4be2-b73d-18d66da5a7ec12018-05-09
0378-7299-85EA - Each0378-7299da09d91f-59e3-478f-8f0f-9a4276b4547712018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7299DROSPIRENONE AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250216_2aad811c-82f4-4dda-94b6-684f84048d86.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7299-53003787299533 POUCH in 1 CARTON (0378-7299-53) > 1 BLISTER PACK in 1 POUCH (0378-7299-85) > 1 KIT in 1 BLISTER PACK3 pouch2018-04-230000-00-00NoNoCurrent