Home NDC 78206-161 REMERON
Product NDC 78206-161
11-digit product format 782060161
Labeler code 78206
Product ID 78206-161_8b121c7c-9bcd-4504-b789-3f551a0fe514
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIRTAZAPINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Organon LLC
Application NDA020415
Marketing category NDA
Marketing start 2021-06-01
Substance MIRTAZAPINE
Active strength 30 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020415-001 REMERON MIRTAZAPINE 15MG TABLET / ORAL AB RLD, RS 1996-06-14 N020415-002 REMERON MIRTAZAPINE 30MG TABLET / ORAL AB RLD 1996-06-14 N020415-003 REMERON MIRTAZAPINE 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 123 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 2026-02-19 14:30 UTC 2026-02 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020415-002 REMERON 30MG TABLET / ORAL AB RLD 1996-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020415-003 REMERON 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020415-001 REMERON 15MG TABLET / ORAL AB RLD, RS 1996-06-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base REMERON
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIRTAZAPINE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A051Q2099Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 211322 Internal RxNorm lookup 211323 Internal RxNorm lookup 283406 Internal RxNorm lookup 283407 Internal RxNorm lookup 283485 Internal RxNorm lookup 311725 Internal RxNorm lookup 314111 Internal RxNorm lookup 752869 Internal RxNorm lookup 752870 Internal RxNorm lookup 752871 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 78206-161-01 REMERON 30 in 1 BOTTLE TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-161 REMERON (MIRTAZAPINE) TABLET, FILM COATED REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON LLC] 7 Current NDC, Legacy NDC, 1 package rows 20250312_98ad1917-a094-44f5-a28f-a64a8cfcd887.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 78206-161-01 78206016101 30 TABLET, FILM COATED in 1 BOTTLE (78206-161-01) 2021-06-01 0000-00-00 No No Current