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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-6023-89 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0378-6023-89 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0378-6023-89 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0378-6023-89 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0378-6023-89 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0378-6023-89 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0378-6023-89 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0378-6023-89 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0378-6023-89 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0378-6023-89 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0378-6023-89 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0378-6023-89 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 4 · 129 observed 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 2026-09-14 22:38:34 2026-08 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065377-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL 2006-11-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065377-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL 2006-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065377-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL 2006-11-07 301d65b070ca…
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