mirtazapine

Product NDC: 72865-371
Requested package NDC: 72865-371-05
11-digit product format: 728650371
Labeler code: 72865
Product ID: 72865-371_5cc67a1a-2e3d-3916-e063-6294a90a1eca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: XLCare Pharmaceuticals Inc.
Application: ANDA219721
Marketing category: ANDA
Marketing start: 2025-10-02
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	Approval date
A219721-001	MIRTAZAPINE	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2025-10-02
A219721-002	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2025-10-02
A219721-003	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2025-10-02
A219721-004	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2025-10-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A219721-001	AB
A219721-002	AB
A219721-003	AB
A219721-004	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219721-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2025-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219721-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2025-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219721-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2025-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219721-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2025-10-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219721-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2025-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219721-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2025-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219721-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2025-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219721-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2025-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219721-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2025-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219721-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2025-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219721-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2025-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219721-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2025-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219721-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2025-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219721-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2025-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219721-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2025-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219721-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2025-10-02	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219721-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2025-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219721-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2025-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219721-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2025-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219721-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2025-10-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219721-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219721-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219721-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219721-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219721-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219721-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219721-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219721-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219721-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219721-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219721-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219721-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219721-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219721-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219721-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219721-004	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219721-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219721-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219721-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219721-004	AB	1	`a50c72e98297…`

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	45 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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mirtazapine	MIRTAZAPINE	XLCare Pharmaceuticals Inc.	b6b31703-e77d-4d1a-b1ac-da972117e356	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219721 application number: ANDA219721 ndc (package): 72865-371-05 ndc (product): 72865-371 ndc11 (package): 72865037105
mirtazapine	MIRTAZAPINE	A-S Medication Solutions	222dfdde-6979-4b18-a7eb-ff1ad0a437c1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219721 application number: ANDA219721
mirtazapine	MIRTAZAPINE	Camber Pharmaceuticals, Inc.	b4b9b66e-87a1-4dbb-9eaf-71221bcb2265	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219721 application number: ANDA219721

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A051Q2099Q	MIRTAZAPINE	85650-52-8	MIRTAZAPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72865-371-05	72865037105	500 TABLET, FILM COATED in 1 BOTTLE (72865-371-05)	2025-10-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
mirtazapine	XLCare Pharmaceuticals Inc. \| Evaric Pharmaceuticals Inc	2026-10-01	HUMAN PRESCRIPTION DRUG LABEL	3