Acticlate

Product NDC
16110-601
11-digit product format
161100601
Labeler code
16110
Product ID
16110-601_2e463b1b-d30e-4ae6-95c3-853aba0221a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aqua Pharmaceuticals
Application
NDA208253
Marketing category
NDA
Marketing start
2018-05-31
Substance
DOXYCYCLINE HYCLATE
Active strength
75 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
Acticlate
Brand name suffix
CAP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1791505, 1791507

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
16110-601-01ActiclateCAP60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16110-601ACTICLATE CAP (DOXYCYCLINE HYCLATE) CAPSULE [AQUA PHARMACEUTICALS]2Current NDC, Legacy NDC, 1 package rows20180531_5e96d473-63dd-4446-88cf-eef2cd3339f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791507Acticlate 75 MG Oral CapsulePSN5e96d473-63dd-4446-88cf-eef2cd3339f02
1791505doxycycline hyclate 75 MG Oral CapsulePSN5e96d473-63dd-4446-88cf-eef2cd3339f02
1791507doxycycline hyclate 75 MG Oral Capsule [Acticlate]SBD5e96d473-63dd-4446-88cf-eef2cd3339f02
1791505doxycycline hyclate 75 MG Oral CapsuleSCD5e96d473-63dd-4446-88cf-eef2cd3339f02
1791507Acticlate 75 MG (as doxycycline hyclate 86.6 MG) Oral CapsuleSY5e96d473-63dd-4446-88cf-eef2cd3339f02
1791507Acticlate 75 MG Oral CapsuleSY5e96d473-63dd-4446-88cf-eef2cd3339f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16110-601-011611006010160 CAPSULE in 1 BOTTLE (16110-601-01) 60 capsule2018-05-310000-00-00NoNoCurrent