Home NDC 16110-245 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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 16110-245 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 16110-245 16110-245-00 UNFINISHED Active or certified unfinished drug listing 2026-08-17
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209521-001 SEYSARA SARECYCLINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 N209521-002 SEYSARA SARECYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 N209521-003 SEYSARA SARECYCLINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209521-001 9481639 2028-08-10 U-2409 2018-10-12 N209521-001 8513223 2029-12-07 U-2406 2018-10-12 N209521-001 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 N209521-001 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 N209521-001 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 N209521-002 9481639 2028-08-10 U-2409 2018-10-12 N209521-002 8513223 2029-12-07 U-2406 2018-10-12 N209521-002 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 N209521-002 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 N209521-002 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 N209521-003 9481639 2028-08-10 U-2409 2018-10-12 N209521-003 8513223 2029-12-07 U-2406 2018-10-12 N209521-003 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 N209521-003 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 N209521-003 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209521-002 SEYSARA EQ 100MG BASE TABLET / ORAL RLD 2018-10-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209521-003 SEYSARA EQ 150MG BASE TABLET / ORAL RLD, RS 2018-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209521-001 SEYSARA EQ 60MG BASE TABLET / ORAL RLD 2018-10-01 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 16 · 630 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209521-001 9481639 2028-08-10 U-2409 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-001 8513223 2029-12-07 U-2406 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-001 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-001 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-001 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-002 9481639 2028-08-10 U-2409 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-002 8513223 2029-12-07 U-2406 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-002 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-002 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-002 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-003 9481639 2028-08-10 U-2409 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-003 8513223 2029-12-07 U-2406 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-003 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-003 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209521-003 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209521-001 9481639 2028-08-10 U-2409 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-001 8513223 2029-12-07 U-2406 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-001 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-001 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-001 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-002 9481639 2028-08-10 U-2409 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-002 8513223 2029-12-07 U-2406 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-002 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-002 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-002 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-003 9481639 2028-08-10 U-2409 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-003 8513223 2029-12-07 U-2406 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-003 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-003 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209521-003 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-001 9481639 2028-08-10 U-2409 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-001 8513223 2029-12-07 U-2406 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-001 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-001 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-001 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-002 9481639 2028-08-10 U-2409 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-002 8513223 2029-12-07 U-2406 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-002 8318706 2032-01-03 U-2405 Drug substance, Drug product 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-002 9255068 2033-02-09 U-2408 Drug substance, Drug product 2018-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209521-002 9255068 2033-02-09 U-2407 Drug substance, Drug product 2018-10-12 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Seysara
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SARECYCLINE HYDROCHLORIDE 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 36718856JR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2059023 Internal RxNorm lookup 2059029 Internal RxNorm lookup 2059031 Internal RxNorm lookup 2059033 Internal RxNorm lookup 2059035 Internal RxNorm lookup 2059037 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16110-245-30 Seysara 30 in 1 BOTTLE TABLET, COATED 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16110-245 SEYSARA (SARECYCLINE HYDROCHLORIDE) TABLET, COATED [ALMIRALL, LLC] 12 Current NDC, Legacy NDC, 1 package rows 20240619_b200957c-3004-4988-be97-9fd619a83649.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16110-245-00 16110024500 48000 TABLET, COATED in 1 BAG (16110-245-00) 04-JAN-19 Current 16110-245-30 16110024530 30 TABLET, COATED in 1 BOTTLE (16110-245-30) 2019-01-04 0000-00-00 No No Current