FDA.reportPublic FDA data

Seysara

Product NDC
16110-245
11-digit product format
161100245
Labeler code
16110
Product ID
16110-245_4f9be4df-4e12-4f08-8e6f-cb07926ea5e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sarecycline hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Almirall, LLC
Application
NDA209521
Marketing category
NDA
Marketing start
2019-01-04
Substance
SARECYCLINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
P-Glycoprotein Inhibitors [MoA], 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
Seysara
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SARECYCLINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36718856JR
Rxcui2059023, 2059029, 2059031, 2059033, 2059035, 2059037

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
0f3f7b5b-f7b5-4758-a392-9c402d411189Product name120190111
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16110-245-30Seysara30 in 1 BOTTLETABLET, COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16110-245-30EA - Each16110-24551c0ad3a-bbdd-40c8-94ce-a2d0be48eccc12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16110-245SEYSARA (SARECYCLINE HYDROCHLORIDE) TABLET, COATED [ALMIRALL, LLC]12Current NDC, Legacy NDC, 1 package rows20240619_b200957c-3004-4988-be97-9fd619a83649.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059023sarecycline 100 MG Oral TabletPSNb200957c-3004-4988-be97-9fd619a8364912
2059031sarecycline 150 MG Oral TabletPSNb200957c-3004-4988-be97-9fd619a8364912
2059035sarecycline 60 MG Oral TabletPSNb200957c-3004-4988-be97-9fd619a8364912
2059029Seysara 100 MG Oral TabletPSNb200957c-3004-4988-be97-9fd619a8364912
2059033Seysara 150 MG Oral TabletPSNb200957c-3004-4988-be97-9fd619a8364912
2059037Seysara 60 MG Oral TabletPSNb200957c-3004-4988-be97-9fd619a8364912
2059029sarecycline 100 MG Oral Tablet [Seysara]SBDb200957c-3004-4988-be97-9fd619a8364912
2059033sarecycline 150 MG Oral Tablet [Seysara]SBDb200957c-3004-4988-be97-9fd619a8364912
2059037sarecycline 60 MG Oral Tablet [Seysara]SBDb200957c-3004-4988-be97-9fd619a8364912
2059023sarecycline 100 MG Oral TabletSCDb200957c-3004-4988-be97-9fd619a8364912
2059031sarecycline 150 MG Oral TabletSCDb200957c-3004-4988-be97-9fd619a8364912
2059035sarecycline 60 MG Oral TabletSCDb200957c-3004-4988-be97-9fd619a8364912
2059023sarecycline 100 MG (as sarecycline HCl 107.5 MG) Oral TabletSYb200957c-3004-4988-be97-9fd619a8364912
2059031sarecycline 150 MG (as sarecycline HCl 161.2 MG) Oral TabletSYb200957c-3004-4988-be97-9fd619a8364912
2059035sarecycline 60 MG (as sarecycline HCl 64.5 MG) Oral TabletSYb200957c-3004-4988-be97-9fd619a8364912
2059029Seysara 100 MG (as sarecycline HCl 107.5 MG) Oral TabletSYb200957c-3004-4988-be97-9fd619a8364912
2059033Seysara 150 MG (as sarecycline HCl 161.2 MG) Oral TabletSYb200957c-3004-4988-be97-9fd619a8364912
2059037Seysara 60 MG (as sarecycline HCl 64.5 MG) Oral TabletSYb200957c-3004-4988-be97-9fd619a8364912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16110-245-301611002453030 TABLET, COATED in 1 BOTTLE (16110-245-30) 2019-01-040000-00-00NoNoCurrent