Doxycycline Monohydrate

Product NDC
0591-2404
11-digit product format
005912404
Labeler code
0591
Product ID
0591-2404_87ec24be-f5bb-46ef-90fa-d818e0969f07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA050641
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-02-07
Marketing end
2019-06-30
Substance
DOXYCYCLINE
Active strength
75 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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0591-2404DDiscontinued by firm2026-08-17
excluded packagepackage0591-24040591-2404-01DDiscontinued by firm2026-08-17

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-2404-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-2404-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-2404-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-2404-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-2404-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-2404-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-2404-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-2404-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-2404-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-2404-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-2404-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-2404-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050641-001MONODOXDOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRLD1989-12-29
N050641-002MONODOXDOXYCYCLINEEQ 50MG BASECAPSULE / ORALABRLD1992-02-10
N050641-003MONODOXDOXYCYCLINEEQ 75MG BASECAPSULE / ORALABRLD2006-10-18
N050641-004MONODOXDOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRLD2022-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N050641-001AB
N050641-002AB
N050641-003AB
N050641-004AB

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 · 158 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10caaa826d4ba7…
2026-08-18 06:07:402026-07N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N050641-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N050641-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N050641-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N050641-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050641-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050641-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-004AB1d8e5a09893c0…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2404-01EA - Each0591-2404e355c2a0-6435-403f-b69d-3b87faae069d12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.]15

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEWellhouse Pharma, LLC57f97f68-11fb-4900-9efb-ca3b00818d8e2026-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 050641
application number: NDA050641
Doxycycline MonohydrateDOXYCYCLINE MONOHYDRATEChartwell RX, LLC.02aa8731-d40f-43d8-8b63-a79a0503f8db2025-07-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 050641
application number: NDA050641