Home NDC 0093-7208 Mirtazapine
Product NDC 0093-7208
11-digit product format 000937208
Labeler code 0093
Product ID 0093-7208_7064d29d-da21-4a64-9451-a211af369381
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076119
Marketing category ANDA
Marketing start 2003-06-19
Marketing end 2020-01-31
Substance MIRTAZAPINE
Active strength 45 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 · 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 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 0093-7208-56 557ba5c1ecfa…9c80585c8c6e…
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 [TEVA PHARMACEUTICALS USA INC] 13 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13