Doxycycline Hyclate

Product NDC
0378-4535
11-digit product format
003784535
Labeler code
0378
Product ID
0378-4535_8b6c7e11-aab9-40db-a485-c199e97ad552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090431
Marketing category
ANDA
Marketing start
2016-05-23
Marketing end
2022-02-28
Substance
DOXYCYCLINE HYCLATE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4535-78EA - Each0378-453577808fa8-937d-4430-80cb-f3930cb456c512016-06-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4535-7800378453578120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4535-78) 2016-05-232022-02-28NoNoCurrent