FDA.reportPublic FDA data

DOXYCYCLINE

Product NDC
70518-0213
11-digit product format
705180213
Labeler code
70518
Product ID
70518-0213_4ce7a6c7-479e-ea6c-e063-6394a90aaf8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204234
Marketing category
ANDA
Marketing start
2017-02-10
Substance
DOXYCYCLINE
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
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
70518-0213-0DOXYCYCLINE30 in 1 BLISTER PACKCAPSULE3032
70518-0213-1DOXYCYCLINE20 in 1 BLISTER PACKCAPSULE2032
70518-0213-2DOXYCYCLINE14 in 1 BOTTLE, PLASTICCAPSULE1432
70518-0213-3DOXYCYCLINE20 in 1 BOTTLE, PLASTICCAPSULE2032
70518-0213-4DOXYCYCLINE42 in 1 BOTTLE, PLASTICCAPSULE4232
70518-0213-5DOXYCYCLINE2 in 1 BOTTLE, PLASTICCAPSULE232
70518-0213-6DOXYCYCLINE100 in 1 BOTTLE, PLASTICCAPSULE10032
70518-0213-7DOXYCYCLINE14 in 1 BLISTER PACKCAPSULE1432
70518-0213-8DOXYCYCLINE60 in 1 BOTTLE, PLASTICCAPSULE6032
70518-0213-9DOXYCYCLINE30 in 1 BOTTLE, PLASTICCAPSULE3032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0213DOXYCYCLINE CAPSULE [REMEDYREPACK INC.]28Current NDC, Legacy NDC, 10 package rows20250425_fa2d9328-b688-47af-8c4d-dc328cf35392.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSNfa2d9328-b688-47af-8c4d-dc328cf3539232
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDfa2d9328-b688-47af-8c4d-dc328cf3539232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0213-07051802130030 CAPSULE in 1 BLISTER PACK (70518-0213-0) 30 capsule2017-02-100000-00-00NoNoCurrent
70518-0213-17051802130120 CAPSULE in 1 BLISTER PACK (70518-0213-1) 20 capsule2017-02-100000-00-00NoNoCurrent
70518-0213-27051802130214 CAPSULE in 1 BOTTLE, PLASTIC (70518-0213-2) 14 capsule2017-05-310000-00-00NoNoCurrent
70518-0213-37051802130320 CAPSULE in 1 BOTTLE, PLASTIC (70518-0213-3) 20 capsule2017-07-170000-00-00NoNoCurrent
70518-0213-47051802130442 in 1 BOTTLE, PLASTICHistorical
70518-0213-5705180213052 CAPSULE in 1 BOTTLE, PLASTIC (70518-0213-5) 2 capsule2018-01-050000-00-00NoNoCurrent
70518-0213-670518021306100 CAPSULE in 1 BOTTLE, PLASTIC (70518-0213-6) 100 capsule2018-04-260000-00-00NoNoCurrent
70518-0213-77051802130714 CAPSULE in 1 BLISTER PACK (70518-0213-7) 14 capsule2020-03-170000-00-00NoNoCurrent
70518-0213-87051802130860 CAPSULE in 1 BOTTLE, PLASTIC (70518-0213-8) 60 capsule2022-02-140000-00-00NoNoCurrent
70518-0213-97051802130930 in 1 BOTTLE, PLASTICHistorical