Home NDC 0615-8663 Mirtazapine
Product NDC 0615-8663
11-digit product format 006158663
Labeler code 0615
Product ID 0615-8663_65d56a7a-38e7-4132-96d0-d568757472e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA219919
Marketing category ANDA
Marketing start 2026-05-14
Substance MIRTAZAPINE
Active strength 7.5 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 A219919-001 MIRTAZAPINE MIRTAZAPINE 7.5MG TABLET / ORAL AB 2026-02-02 A219919-002 MIRTAZAPINE MIRTAZAPINE 15MG TABLET / ORAL AB 2026-02-02 A219919-003 MIRTAZAPINE MIRTAZAPINE 30MG TABLET / ORAL AB 2026-02-02 A219919-004 MIRTAZAPINE MIRTAZAPINE 45MG TABLET / ORAL AB 2026-02-02
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.
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 A219919-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2026-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219919-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2026-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219919-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2026-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219919-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2026-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219919-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2026-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219919-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2026-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219919-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2026-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219919-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2026-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219919-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2026-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219919-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2026-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219919-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2026-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219919-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2026-02-02 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219919-001 MIRTAZAPINE 7.5MG TABLET / ORAL AB 2026-02-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219919-002 MIRTAZAPINE 15MG TABLET / ORAL AB 2026-02-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219919-003 MIRTAZAPINE 30MG TABLET / ORAL AB 2026-02-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219919-004 MIRTAZAPINE 45MG TABLET / ORAL AB 2026-02-02 a50c72e98297…
Observed Orange Book normalized TE history# 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIRTAZAPINE 7.5 mg/1
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mirtazapine MIRTAZAPINE ANI Pharmaceuticals, Inc. bb134141-6069-4b86-abac-7783bf5df60d 2026-05-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 219919 application number: ANDA219919
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0615-8663-05 00615866305 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8663-05) 2026-09-16 No No Current 0615-8663-39 00615866339 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8663-39) 2026-09-16 No No Current