Home NDC 71610-846-15 Mirtazapine
Product NDC 71610-846
Requested package NDC 71610-846-15
11-digit product format 716100846
Labeler code 71610
Product ID 71610-846_1dffd745-a863-1f0e-e063-6394a90a1fff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA216751
Marketing category ANDA
Marketing start 2023-09-01
Substance MIRTAZAPINE
Active strength 30 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 A216751-001 MIRTAZAPINE MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 A216751-002 MIRTAZAPINE MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 A216751-003 MIRTAZAPINE MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 A216751-004 MIRTAZAPINE MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18
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 3 · 100 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 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216751-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216751-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216751-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216751-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2023-01-18 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 100 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 30 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314111 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 71610-846-15 Mirtazapine 15 in 1 BOTTLE TABLET, FILM COATED 15 1 71610-846-30 Mirtazapine 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71610-846-45 Mirtazapine 45 in 1 BOTTLE TABLET, FILM COATED 45 1 71610-846-53 Mirtazapine 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-846 MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 4 package rows 20240725_1e0006b6-9405-95a7-e063-6294a90aa277.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 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mirtazapine MIRTAZAPINE Aphena Pharma Solutions - Tennessee, LLC 20eafce1-50cd-0d9c-e063-6394a90ad6fe 2024-09-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216751 application number: ANDA216751 Mirtazapine MIRTAZAPINE Aphena Pharma Solutions - Tennessee, LLC 1e0006b6-9405-95a7-e063-6294a90aa277 2024-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216751 application number: ANDA216751 ndc (package): 71610-846-15 ndc (product): 71610-846 ndc11 (package): 71610084615 Mirtazapine MIRTAZAPINE Prasco Laboratories 8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4 2023-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216751 application number: ANDA216751
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71610-846-15 71610084615 15 TABLET, FILM COATED in 1 BOTTLE (71610-846-15) 2024-07-17 No No Current