Home NDC 63187-207 Mirtazapine
Product NDC 63187-207
11-digit product format 631870207
Labeler code 63187
Product ID 63187-207_f5000a4c-d635-4a30-88af-23fe92094293
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA076119
Marketing category ANDA
Marketing start 2003-01-29
Marketing end 0000-00-00
Substance MIRTAZAPINE
Active strength 30 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A076119-001 MIRTAZAPINE MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 A076119-002 MIRTAZAPINE MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 A076119-003 MIRTAZAPINE MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 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 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076119-002 MIRTAZAPINE 30MG TABLET / ORAL AB 2003-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076119-003 MIRTAZAPINE 45MG TABLET / ORAL AB 2003-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076119-001 MIRTAZAPINE 15MG TABLET / ORAL AB 2003-01-24 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 3