Mirtazapine

Product NDC: 60505-0249
11-digit product format: 605050249
Labeler code: 60505
Product ID: 60505-0249_c076cd92-b06d-b317-cc04-6f99b3718cf7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA077666
Marketing category: ANDA
Marketing start: 2007-08-22
Substance: MIRTAZAPINE
Active strength: 45 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077666-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22
A077666-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22
A077666-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077666-001	AB
A077666-002	AB
A077666-003	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.

Product history page 1 of 4 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077666-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2007-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077666-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2007-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077666-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2007-08-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077666-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077666-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077666-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077666-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077666-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077666-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077666-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077666-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077666-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077666-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077666-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077666-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077666-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077666-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077666-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077666-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077666-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077666-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077666-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077666-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077666-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077666-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mirtazapine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIRTAZAPINE	45 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311725	Internal RxNorm lookup
311726	Internal RxNorm lookup
314111	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9675333e-3064-c8cb-a4b4-6c74d9a82f17	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5	Product name	3	20240216
a733d273-402b-1005-9891-1ac1a9c63703	Product name	2	20170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-0249-1	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	20
60505-0249-3	Mirtazapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	20
60505-0249-5	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	20
60505-0249-8	Mirtazapine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0249-1	EA - Each	60505-0249	65fb1cdb-7bae-4e9b-a613-25b6e2096546	1	2013-02-13
60505-0249-8	EA - Each	60505-0249	4b74bdf0-da15-4f0c-b688-b90dd4c52790	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	4
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYPROMELLOSE 2910 (6 CPS)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC. ]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0249	MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.]	19	Current NDC, Legacy NDC, 4 package rows	20241105_9675333e-3064-c8cb-a4b4-6c74d9a82f17.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	A-S Medication Solutions	44779383-3ddb-41df-8766-da5d7bef385e	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Direct_Rx	dea8c09a-b759-1da7-e053-2a95a90a3346	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	df06ea51-a962-49d0-a449-137e2220ce7e	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Apotex Corp.	9675333e-3064-c8cb-a4b4-6c74d9a82f17	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666 ndc (product): 60505-0249
Mirtazapine	MIRTAZAPINE	Coupler LLC	3eed8213-a240-fc4b-e063-6294a90a3b05	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Major Pharmaceuticals	a80463be-f2d2-4074-9bd8-5e52b0832b3a	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	AvKARE	35922615-7619-3852-e063-6394a90a2e55	2025-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	McKesson Corporation dba SKY Packaging	40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	ac976282-fb68-4db0-912a-28f075b0716c	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	faba9bfd-6725-4917-ab48-24e58b397eb4	2023-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Proficient Rx LP	3b516a33-b164-4e4f-bc18-e9d1e591323a	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666
Mirtazapine	MIRTAZAPINE	Proficient Rx LP	a2f01ffd-fd48-499b-9126-8eb9048a5722	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077666 application number: ANDA077666

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311725	mirtazapine 15 MG Oral Tablet	PSN	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
314111	mirtazapine 30 MG Oral Tablet	PSN	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
311726	mirtazapine 45 MG Oral Tablet	PSN	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
311725	mirtazapine 15 MG Oral Tablet	SCD	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
314111	mirtazapine 30 MG Oral Tablet	SCD	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
311726	mirtazapine 45 MG Oral Tablet	SCD	9675333e-3064-c8cb-a4b4-6c74d9a82f17	20
311726	mirtazapine 45 MG Oral Tablet	PSN	82a644f9-d9f6-4398-83db-8a1446c183e0	5
311726	mirtazapine 45 MG Oral Tablet	SCD	82a644f9-d9f6-4398-83db-8a1446c183e0	5
311725	mirtazapine 15 MG Oral Tablet	PSN	3b516a33-b164-4e4f-bc18-e9d1e591323a	4
311726	mirtazapine 45 MG Oral Tablet	PSN	3b516a33-b164-4e4f-bc18-e9d1e591323a	4
311725	mirtazapine 15 MG Oral Tablet	SCD	3b516a33-b164-4e4f-bc18-e9d1e591323a	4
311726	mirtazapine 45 MG Oral Tablet	SCD	3b516a33-b164-4e4f-bc18-e9d1e591323a	4
311725	mirtazapine 15 MG Oral Tablet	PSN	34c0b734-98ca-4aec-965f-e55edd3317f3	2
314111	mirtazapine 30 MG Oral Tablet	PSN	34c0b734-98ca-4aec-965f-e55edd3317f3	2
311726	mirtazapine 45 MG Oral Tablet	PSN	34c0b734-98ca-4aec-965f-e55edd3317f3	2
311726	mirtazapine 45 MG Oral Tablet	PSN	e7f84b73-ec3f-4638-b5a7-e0feafbe9277	2
311725	mirtazapine 15 MG Oral Tablet	SCD	34c0b734-98ca-4aec-965f-e55edd3317f3	2
314111	mirtazapine 30 MG Oral Tablet	SCD	34c0b734-98ca-4aec-965f-e55edd3317f3	2
311726	mirtazapine 45 MG Oral Tablet	SCD	34c0b734-98ca-4aec-965f-e55edd3317f3	2
311726	mirtazapine 45 MG Oral Tablet	SCD	e7f84b73-ec3f-4638-b5a7-e0feafbe9277	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0249-1	60505024901	30 TABLET, FILM COATED in 1 BOTTLE (60505-0249-1)	2007-08-22	0000-00-00	No	No	Current
60505-0249-3	60505024903	100 TABLET, FILM COATED in 1 BOTTLE (60505-0249-3)	2007-08-22	0000-00-00	No	No	Current
60505-0249-5	60505024905	500 TABLET, FILM COATED in 1 BOTTLE (60505-0249-5)	2007-08-22	0000-00-00	No	No	Current
60505-0249-8	60505024908	1000 TABLET, FILM COATED in 1 BOTTLE (60505-0249-8)	2007-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Apotex Corp. \| Apotex Inc	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	20
Mirtazapine	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Mirtazapine Tablets, USP 15 mg, and 45 mg Rx Only	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Mirtazapine	Bryant Ranch Prepack	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	101
MIRTAZAPINE TABLETS, USP 15 mg, 30 mg and 45 mg Rx Only	Preferred Pharmaceuticals Inc.	2019-10-31	HUMAN PRESCRIPTION DRUG LABEL	2
MIRTAZAPINE TABLETS, USP 15 mg, 30 mg and 45 mg Rx Only	REMEDYREPACK INC.	2018-05-04	HUMAN PRESCRIPTION DRUG LABEL	3
MIRTAZAPINE	Direct Rx	2016-10-24	HUMAN PRESCRIPTION DRUG LABEL	2
Mirtazapine Tablets, USP	State of Florida DOH Central Pharmacy	2010-08-06	HUMAN PRESCRIPTION DRUG LABEL	2