Home NDC 13107-032 Mirtazapine
Product NDC 13107-032
11-digit product format 131070032
Labeler code 13107
Product ID 13107-032_4329eeed-8071-4b6c-887d-0cd00647b84c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurolife Pharma LLC
Application ANDA076921
Marketing category ANDA
Marketing start 2009-08-17
Substance MIRTAZAPINE
Active strength 45 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076921-001 MIRTAZAPINE MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 A076921-002 MIRTAZAPINE MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 A076921-003 MIRTAZAPINE MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 A076921-004 MIRTAZAPINE MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 2026-09-14 22:38:34 2026-08 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076921-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2004-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076921-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2004-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076921-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2004-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076921-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2004-10-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mirtazapine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIRTAZAPINE 45 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311725 Internal RxNorm lookup 311726 Internal RxNorm lookup 314111 Internal RxNorm lookup 476809 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 13107-032-01 Mirtazapine 100 in 1 BOTTLE TABLET, FILM COATED 100 14 13107-032-05 Mirtazapine 500 in 1 BOTTLE TABLET, FILM COATED 500 14 13107-032-32 Mirtazapine 30 in 1 BLISTER PACK TABLET, FILM COATED 30 14 13107-032-34 Mirtazapine 30 in 1 BOTTLE TABLET, FILM COATED 30 14 13107-032-60 Mirtazapine 60 in 1 BOTTLE TABLET, FILM COATED 60 14 13107-032-90 Mirtazapine 90 in 1 BOTTLE TABLET, FILM COATED 90 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Mirtazapine ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 Mirtazapine ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 7 Mirtazapine ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 Mirtazapine ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 5 Mirtazapine ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 Mirtazapine ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-032 MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC] 13 Current NDC, Legacy NDC, 6 package rows 20240126_aa05d606-29fd-443e-802b-1d65584d6bb1.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 3 of 3 · 44 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mirtazapine MIRTAZAPINE Proficient Rx LP a96e0d95-1a7b-4588-923a-2169b5506203 2021-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076921 application number: ANDA076921 Mirtazapine MIRTAZAPINE NCS HealthCare of KY, Inc dba Vangard Labs 20a724c6-feba-40e7-a35a-8a37de2e0136 2019-03-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076921 application number: ANDA076921 Mirtazapine MIRTAZAPINE Aphena Pharma Solutions - Tennessee, LLC 3bda4994-cdf5-47b4-aebc-7297347334e9 2018-08-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076921 application number: ANDA076921 Mirtazapine MIRTAZAPINE Aphena Pharma Solutions - Tennessee, LLC 6ad0e695-92ee-4900-b194-a2455473370b 2018-07-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076921 application number: ANDA076921
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 13107-032-01 13107003201 100 TABLET, FILM COATED in 1 BOTTLE (13107-032-01) 2009-08-17 0000-00-00 No No Current 13107-032-05 13107003205 500 TABLET, FILM COATED in 1 BOTTLE (13107-032-05) 2009-08-17 0000-00-00 No No Current 13107-032-32 13107003232 30 TABLET, FILM COATED in 1 BLISTER PACK (13107-032-32) 2009-08-17 0000-00-00 No No Current 13107-032-34 13107003234 30 TABLET, FILM COATED in 1 BOTTLE (13107-032-34) 2009-08-17 0000-00-00 No No Current 13107-032-60 13107003260 60 TABLET, FILM COATED in 1 BOTTLE (13107-032-60) 2009-08-17 0000-00-00 No No Current 13107-032-90 13107003290 90 TABLET, FILM COATED in 1 BOTTLE (13107-032-90) 2009-08-17 0000-00-00 No No Current