FDA.reportPublic FDA data

doxycycline

Product NDC
70518-3488
11-digit product format
705183488
Labeler code
70518
Product ID
70518-3488_51257dc2-a29a-46a7-e063-6394a90ae062
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209402
Marketing category
ANDA
Marketing start
2022-08-22
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
doxycycline
Listing expiration
2027-12-31

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
70518-3488-0doxycycline20 in 1 BLISTER PACKCAPSULE2018
70518-3488-1doxycycline30 in 1 BLISTER PACKCAPSULE3018
70518-3488-2doxycycline14 in 1 BOTTLE, PLASTICCAPSULE1418
70518-3488-3doxycycline28 in 1 BOTTLE, PLASTICCAPSULE2818
70518-3488-4doxycycline20 in 1 BOTTLE, PLASTICCAPSULE2018
70518-3488-5doxycycline180 in 1 BOTTLE, PLASTICCAPSULE18018
70518-3488-6doxycycline56 in 1 BOTTLE, PLASTICCAPSULE5618
70518-3488-7doxycycline30 in 1 BOTTLE, PLASTICCAPSULE3018
70518-3488-8doxycycline50 in 1 BOTTLE, PLASTICCAPSULE5018
70518-3488-9doxycycline20 in 1 BOTTLE, PLASTICCAPSULE2018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3488-4EA - Each70518-34880fb9e860-0324-4d69-b258-32a9b5e06b0412026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3488DOXYCYCLINE CAPSULE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 10 package rows20250418_f0fbf63a-e75c-40cf-b2e9-429deaac899d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNf0fbf63a-e75c-40cf-b2e9-429deaac899d18
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf0fbf63a-e75c-40cf-b2e9-429deaac899d18
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf0fbf63a-e75c-40cf-b2e9-429deaac899d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3488-07051834880020 CAPSULE in 1 BLISTER PACK (70518-3488-0) 20 capsule2022-08-220000-00-00NoNoCurrent
70518-3488-17051834880130 CAPSULE in 1 BLISTER PACK (70518-3488-1) 30 capsule2022-09-070000-00-00NoNoCurrent
70518-3488-27051834880214 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-2) 14 capsule2022-12-140000-00-00NoNoCurrent
70518-3488-37051834880328 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-3) 28 capsule2023-08-02NoNoHistorical
70518-3488-47051834880420 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-4) 20 capsule2023-10-24NoNoHistorical
70518-3488-570518348805180 in 1 BOTTLE, PLASTICHistorical
70518-3488-67051834880656 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-6) 56 capsule2025-02-27NoNoHistorical
70518-3488-77051834880730 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-7) 30 capsule2025-08-22NoNoHistorical
70518-3488-87051834880850 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-8) 50 capsule2025-11-17NoNoHistorical
70518-3488-97051834880920 CAPSULE in 1 BOTTLE, PLASTIC (70518-3488-9) 20 capsule2026-05-05NoNoHistorical