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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-6124DDiscontinued by firm2026-08-03
excluded packagepackage0378-61240378-6124-93DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065427-001DOXYCYCLINEDOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-073f01610625f2…
2019-09-15 20:21 UTC2019-09A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6124-93EA - Each0378-6124f59da852-f7a6-4641-bd96-c44b447e3f2812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TRIACETININACTIVE INGREDIENTXHX3C3X673DOXYCYCLINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8