FDA.reportPublic FDA data

doxycycline

Product NDC
63187-712
11-digit product format
631870712
Labeler code
63187
Product ID
63187-712_3aba6b55-812d-44e3-95e2-7be62d33db53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205115
Marketing category
ANDA
Marketing start
2016-03-14
Substance
DOXYCYCLINE
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
DOXYCYCLINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O
Rxcui1649990

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
63187-712-14doxycycline14 in 1 BOTTLECAPSULE143
63187-712-20doxycycline20 in 1 BOTTLECAPSULE203
63187-712-30doxycycline30 in 1 BOTTLECAPSULE303
63187-712-60doxycycline60 in 1 BOTTLECAPSULE603
63187-712-90doxycycline90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-712-14EA - Each63187-71236beaebb-e2cd-4bfe-9625-dc07f6b3300512018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-712DOXYCYCLINE CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20191121_f3ba6c30-ada3-4a57-9ff8-30558202b9aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSNf3ba6c30-ada3-4a57-9ff8-30558202b9aa3
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDf3ba6c30-ada3-4a57-9ff8-30558202b9aa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-712-146318707121414 CAPSULE in 1 BOTTLE (63187-712-14) 14 capsule2016-06-010000-00-00NoNoCurrent
63187-712-206318707122020 CAPSULE in 1 BOTTLE (63187-712-20) 20 capsule2016-06-010000-00-00NoNoCurrent
63187-712-306318707123030 CAPSULE in 1 BOTTLE (63187-712-30) 30 capsule2016-06-010000-00-00NoNoCurrent
63187-712-606318707126060 CAPSULE in 1 BOTTLE (63187-712-60) 60 capsule2016-06-010000-00-00NoNoCurrent
63187-712-906318707129090 CAPSULE in 1 BOTTLE (63187-712-90) 90 capsule2016-06-010000-00-00NoNoCurrent