FDA.reportPublic FDA data

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065427-001DOXYCYCLINEEQ 150MG BASETABLET / ORAL2007-06-07a50c72e98297…

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