Home NDC 70954-830 Mirtazapine
Product NDC 70954-830
11-digit product format 709540830
Labeler code 70954
Product ID 70954-830_2e513b1e-938d-44be-a6d9-9f22428aee8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
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
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 70954-830-10 Mirtazapine 30 in 1 BOTTLE TABLET, FILM COATED 30 3
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70954-830-10 70954083010 30 TABLET, FILM COATED in 1 BOTTLE (70954-830-10) 2026-05-14 No No Current