Home NDC 68071-4989 Mirtazapine
Product NDC 68071-4989
11-digit product format 680714989
Labeler code 68071
Product ID 68071-4989_1b305c50-b2f3-6e01-e063-6394a90a0ce1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA076921
Marketing category ANDA
Marketing start 2004-10-22
Substance MIRTAZAPINE
Active strength 30 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 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 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4989-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4989-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4989-3 1332a3947898…d4bfe170f9cd…
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 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# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2024-06-26 Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only 2023-01-30 Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only 2021-02-19 Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only 2021-01-29 Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4989-3 Mirtazapine 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4989 MIRTAZAPINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240627_8e839bb2-2f67-f224-e053-2a95a90ae5d8.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 68071-4989-3 68071498903 30 TABLET, FILM COATED in 1 BOTTLE (68071-4989-3) 2019-07-25 0000-00-00 No No Current