FDA.reportPublic FDA data

Doxycyclate Hyclate

Product NDC
70518-1627
11-digit product format
705181627
Labeler code
70518
Product ID
70518-1627_4ef85f00-9f10-c2c2-e063-6394a90a0716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA062396
Marketing category
ANDA
Marketing start
2018-11-02
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
Doxycyclate Hyclate
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
70518-1627-0Doxycyclate Hyclate30 in 1 BLISTER PACKCAPSULE3025
70518-1627-1Doxycyclate Hyclate20 in 1 BOTTLE, PLASTICCAPSULE2025
70518-1627-2Doxycyclate Hyclate180 in 1 BOTTLE, PLASTICCAPSULE18025
70518-1627-3Doxycyclate Hyclate20 in 1 BLISTER PACKCAPSULE2025
70518-1627-4Doxycyclate Hyclate14 in 1 BOTTLE, PLASTICCAPSULE1425
70518-1627-5Doxycyclate Hyclate14 in 1 BOTTLE, PLASTICCAPSULE1425
70518-1627-6Doxycyclate Hyclate50 in 1 BOTTLE, PLASTICCAPSULE5025
70518-1627-7Doxycyclate Hyclate20 in 1 BOTTLE, PLASTICCAPSULE2025
70518-1627-8Doxycyclate Hyclate28 in 1 BOTTLE, PLASTICCAPSULE2825
70518-1627-9Doxycyclate Hyclate56 in 1 BOTTLE, PLASTICCAPSULE5625

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1627DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [REMEDYREPACK INC.]20Current NDC, Legacy NDC, 10 package rows20250215_4dc319c1-b7ef-40e4-9e66-fb24cfdefea8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN4dc319c1-b7ef-40e4-9e66-fb24cfdefea825
1649988doxycycline hyclate 100 MG Oral CapsuleSCD4dc319c1-b7ef-40e4-9e66-fb24cfdefea825
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY4dc319c1-b7ef-40e4-9e66-fb24cfdefea825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1627-07051816270030 CAPSULE in 1 BLISTER PACK (70518-1627-0) 30 capsule2018-11-020000-00-00NoNoCurrent
70518-1627-17051816270120 CAPSULE in 1 BOTTLE, PLASTIC (70518-1627-1) 20 capsule2018-12-170000-00-00NoNoCurrent
70518-1627-270518162702180 CAPSULE in 1 BOTTLE, PLASTIC (70518-1627-2) 180 capsule2019-07-170000-00-00NoNoCurrent
70518-1627-37051816270320 CAPSULE in 1 BLISTER PACK (70518-1627-3) 20 capsule2019-08-120000-00-00NoNoCurrent
70518-1627-47051816270414 CAPSULE in 1 BOTTLE, PLASTIC (70518-1627-4) 14 capsule2020-10-200000-00-00NoNoCurrent
70518-1627-57051816270514 CAPSULE in 1 BOTTLE, PLASTIC (70518-1627-5) 14 capsule2021-07-150000-00-00NoNoCurrent
70518-1627-67051816270650 CAPSULE in 1 BOTTLE, PLASTIC (70518-1627-6) 50 capsule2022-03-300000-00-00NoNoCurrent
70518-1627-77051816270720 CAPSULE in 1 BOTTLE, PLASTIC (70518-1627-7) 20 capsule2022-06-080000-00-00NoNoCurrent
70518-1627-87051816270828 CAPSULE in 1 BOTTLE, PLASTIC (70518-1627-8) 28 capsule2023-06-14NoNoHistorical
70518-1627-97051816270956 CAPSULE in 1 BOTTLE, PLASTIC (70518-1627-9) 56 capsule2023-06-15NoNoHistorical