Home NDC 0378-6124 Doxycycline
Product NDC 0378-6124
11-digit product format 003786124
Labeler code 0378
Product ID 0378-6124_6685d759-9360-4b11-88f7-1679699152d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA065427
Marketing category ANDA
Marketing start 2007-06-08
Marketing end 2019-04-30
Substance DOXYCYCLINE
Active strength 150 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065427-001 DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065427-001 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL 2007-06-07 cb3db0bc1861…
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