Home NDC 0591-1117 Mirtazapine
Product NDC 0591-1117
11-digit product format 005911117
Labeler code 0591
Product ID 0591-1117_7efd691f-59a7-4fae-961f-68b7fc609a7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA076312
Marketing category ANDA
Marketing start 2003-06-19
Marketing end 2020-03-31
Substance MIRTAZAPINE
Active strength 15 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 · 36 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 A076312-001 MIRTAZAPINE MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 A076312-002 MIRTAZAPINE MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 A076312-003 MIRTAZAPINE MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19
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 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076312-002 MIRTAZAPINE 30MG TABLET / ORAL 2003-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076312-003 MIRTAZAPINE 45MG TABLET / ORAL 2003-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076312-001 MIRTAZAPINE 15MG TABLET / ORAL 2003-06-19 1e350fbaab3a…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings#