FDA.reportPublic FDA data

doxycycline hyclate

Product NDC
0378-0167
11-digit product format
003780167
Labeler code
0378
Product ID
0378-0167_a579dcec-b792-4dbe-9f9b-987b19beb1ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA062432
Marketing category
ANDA
Marketing start
1983-02-15
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-0167DDiscontinued by firm2026-08-03
excluded productproduct0378-0167DDiscontinued by firm2026-08-03
excluded packagepackage0378-01670378-0167-05DDiscontinued by firm2026-08-03
excluded packagepackage0378-01670378-0167-89DDiscontinued by firm2026-08-03
excluded packagepackage0378-01670378-0167-02DDiscontinued by firm2026-08-03
excluded packagepackage0378-01670378-0167-13DDiscontinued 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
A062432-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORAL1983-02-15

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 22:54:322026-06A062432-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORAL1983-02-15a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0167-02EA - Each0378-0167c8258fd6-def6-4106-8b5a-193e18e6b60512024-09-09
0378-0167-05EA - Each0378-0167a89c60a7-99c2-4233-93b3-ae7d3d00c20f12014-07-02
0378-0167-13EA - Each0378-016726d266cf-d8e7-4e78-9815-d27d37e7b4e812024-09-09
0378-0167-89EA - Each0378-0167ab899fd6-093a-498b-b4cd-65c77ae5b3f212014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
SHELLACINACTIVE INGREDIENT46N107B71ODOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [MYLAN PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0167DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]21Legacy NDC20250522_17007484-15f7-4651-9c13-7cc809f403dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0167-0500378016705500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0167-05) 1983-02-150000-00-00NoNoCurrent
0378-0167-890037801678950 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0167-89) 1983-02-150000-00-00NoNoCurrent