Home NDC 0052-0107 REMERON
Product NDC 0052-0107
11-digit product format 000520107
Labeler code 0052
Product ID 0052-0107_325197a6-1a5f-4c6f-bb05-c8b3f64ce3ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIRTAZAPINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Organon USA Inc.
Application NDA020415
Marketing category NDA
Marketing start 1996-06-14
Marketing end 0000-00-00
Substance MIRTAZAPINE
Active strength 30 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0052-0107-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0052-0107-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0052-0107-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0052-0107-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0052-0107-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0052-0107-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0052-0107-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0052-0107-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0052-0107-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0052-0107-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0052-0107-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0052-0107-30 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.] 19 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.] 19 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.] 19 LACTOSE INACTIVE INGREDIENT J2B2A4N98G REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.] 19 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.] 19 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.] 19 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ REMERON (MIRTAZAPINE) TABLET, FILM COATED [ORGANON USA INC.] 19 MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1
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 Units Marketing start Marketing end Sample Exclude flag Status 0052-0107-30 00052010730 1 BOTTLE in 1 CARTON (0052-0107-30) > 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1996-06-14 0000-00-00 No No Current