FDA.reportPublic FDA data

doxycycline

Product NDC
82804-046
11-digit product format
828040046
Labeler code
82804
Product ID
82804-046_20caa725-6795-40f3-a381-86c9f89c27bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209402
Marketing category
ANDA
Marketing start
2021-11-19
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
doxycycline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649988

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-046-06doxycycline6 in 1 BOTTLECAPSULE62
82804-046-14doxycycline14 in 1 BOTTLECAPSULE142
82804-046-20doxycycline20 in 1 BOTTLECAPSULE202
82804-046-42doxycycline42 in 1 BOTTLECAPSULE422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-046-06EA - Each82804-046ea11552a-9676-438c-986b-b84c960a7c0112024-02-14
82804-046-14EA - Each82804-0460bb80441-bb37-4092-bc46-ce5fdfcdaa0912024-02-14
82804-046-20EA - Each82804-0467170fe87-fc48-4854-af09-5c6cdf951da912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-046DOXYCYCLINE CAPSULE [PROFICIENT RX LP]2Current NDC, 4 package rows20240805_716dccec-7480-44dd-91b9-249ae2c25088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN716dccec-7480-44dd-91b9-249ae2c250882
1649988doxycycline hyclate 100 MG Oral CapsuleSCD716dccec-7480-44dd-91b9-249ae2c250882
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY716dccec-7480-44dd-91b9-249ae2c250882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-046-06828040046066 CAPSULE in 1 BOTTLE (82804-046-06) 6 capsule2023-12-08NoNoCurrent
82804-046-148280400461414 CAPSULE in 1 BOTTLE (82804-046-14) 14 capsule2023-12-08NoNoCurrent
82804-046-208280400462020 CAPSULE in 1 BOTTLE (82804-046-20) 20 capsule2023-12-08NoNoCurrent
82804-046-428280400464242 CAPSULE in 1 BOTTLE (82804-046-42) 42 capsule2024-08-01NoNoCurrent