doxycycline hyclate

Product NDC
0378-0167
11-digit product format
003780167
Labeler code
0378
Product ID
0378-0167_a579dcec-b792-4dbe-9f9b-987b19beb1ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA062432
Marketing category
ANDA
Marketing start
1983-02-15
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0167-02EA - Each0378-0167c8258fd6-def6-4106-8b5a-193e18e6b60512024-09-09
0378-0167-05EA - Each0378-0167a89c60a7-99c2-4233-93b3-ae7d3d00c20f12014-07-02
0378-0167-13EA - Each0378-016726d266cf-d8e7-4e78-9815-d27d37e7b4e812024-09-09
0378-0167-89EA - Each0378-0167ab899fd6-093a-498b-b4cd-65c77ae5b3f212014-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0167DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]21Legacy NDC20250522_17007484-15f7-4651-9c13-7cc809f403dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0167-0500378016705500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0167-05) 1983-02-150000-00-00NoNoCurrent
0378-0167-890037801678950 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0167-89) 1983-02-150000-00-00NoNoCurrent