FDA.reportPublic FDA data

Doxycycline Monohydrate

Product NDC
0591-0410
11-digit product format
005910410
Labeler code
0591
Product ID
0591-0410_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
2005-02-07
Marketing end
2020-01-31
Substance
DOXYCYCLINE
Active strength
50 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 productproduct0591-0410DDiscontinued by firm2026-08-03
excluded packagepackage0591-04100591-0410-01DDiscontinued 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 · 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29a50c72e98297…
2026-08-01 22:54:322026-06N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10a50c72e98297…
2026-08-01 22:54:322026-06N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18a50c72e98297…
2026-08-01 22:54:322026-06N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N050641-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N050641-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N050641-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N050641-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0410-01EA - Each0591-0410b505dbf6-cc7a-426e-ade6-8a812485b77d12012-07-24

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