Home NDC 0378-6023 Doxycycline
Product NDC 0378-6023
11-digit product format 003786023
Labeler code 0378
Product ID 0378-6023_6685d759-9360-4b11-88f7-1679699152d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA065377
Marketing category ANDA
Marketing start 2006-11-17
Marketing end 2019-04-30
Substance DOXYCYCLINE
Active strength 100 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065377-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 A065377-002 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 A065377-003 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8