Mirtazapine

Product NDC: 65862-031
11-digit product format: 658620031
Labeler code: 65862
Product ID: 65862-031_e26778b1-5226-4107-9d12-3e8b7038bccc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mirtazapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA076921
Marketing category: ANDA
Marketing start: 2004-10-22
Substance: MIRTAZAPINE
Active strength: 15 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	65862-031		UNFINISHED	Active or certified unfinished drug listing		2026-08-17
unfinished package	package	65862-031	65862-031-19	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

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 · 42 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
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-031-19	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-031-19	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-031-19	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-031-19	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-031-19	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-031-19	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-031-19	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-031-19	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-031-19	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-031-19	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-031-19	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-031-19	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-031-19	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-031-19	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-031-19	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-031-19	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-031-19	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-031-19	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-031-19	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-031-19	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-031-19	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
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.

Application-product, TE code table
Application-product	TE code
A076921-001	AB
A076921-002	AB
A076921-003	AB
A076921-004	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.

Product history page 1 of 5 · 168 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
2026-08-18 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-001	MIRTAZAPINE	7.5MG	TABLET / ORAL	AB	2004-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-002	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2004-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-003	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2004-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-004	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2004-10-22	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076921-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076921-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076921-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076921-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076921-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076921-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076921-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076921-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076921-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076921-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIRTAZAPINE	15 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a4c012f0-50b6-42fb-9f06-a14632f23f2e	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
65862-031-01	Mirtazapine	100 in 1 BOTTLE	TABLET, FILM COATED	100	19
65862-031-05	Mirtazapine	500 in 1 BOTTLE	TABLET, FILM COATED	500	19
65862-031-30	Mirtazapine	30 in 1 BOTTLE	TABLET, FILM COATED	30	19
65862-031-32	Mirtazapine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	19
65862-031-60	Mirtazapine	60 in 1 BOTTLE	TABLET, FILM COATED	60	19
65862-031-90	Mirtazapine	90 in 1 BOTTLE	TABLET, FILM COATED	90	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-031-01	EA - Each	65862-031	9e9534c6-daf2-4c4a-afa0-9be2e8a1836f	1	2012-07-24
65862-031-05	EA - Each	65862-031	76a7a6d2-4488-4cc0-b64f-d15daab3c07a	1	2012-07-24
65862-031-30	EA - Each	65862-031	67b82f4a-d9b7-495d-9a53-73c53d44b296	1	2012-07-24
65862-031-90	EA - Each	65862-031	c7bbb388-ac15-4fd8-b67d-c45115e65c31	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9
MIRTAZAPINE	ACTIVE INGREDIENT	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
MIRTAZAPINE	ACTIVE MOIETY	A051Q2099Q	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-031	MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	18	Current NDC, Legacy NDC, 6 package rows	20240126_a4c012f0-50b6-42fb-9f06-a14632f23f2e.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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Redpharm Drug	58bea4d8-084f-4c30-e063-6394a90a35cb	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	10ea9d83-19c3-4f3b-a1cc-cfc48b42507f	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	9135e7db-cba4-4150-a69c-fdf2a347a785	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	c22c4325-4f1a-4d12-8039-d3b1263fa3ad	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	ac3716fd-6971-4a70-ae7b-9f5117f3d880	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	2a0689ae-5650-42d1-ac9d-56dd2b467727	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	aae4c58a-5cbd-45ef-b0f9-32bf28204f15	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	American Health Packaging	82a615a0-e74a-49cb-9a57-ffbb3df604d5	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Unit Dose Solutions, Inc.	5539fe37-546b-40a8-e063-6394a90ace1b	2026-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Coupler LLC	538679a1-d474-8e1c-e063-6394a90a15d7	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Coupler LLC	53311d08-9dfa-7bb1-e063-6394a90a6656	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Coupler LLC	51269807-2b5a-e7aa-e063-6394a90ab657	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Coupler LLC	50718832-88fb-dec1-e063-6294a90ae468	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	A-S Medication Solutions	552e2261-53db-4a27-b277-f7b62c3ea2ed	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	f54718d1-3ef7-4472-9e97-90e5fd30db4d	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	6b6e946c-54b5-40e3-918f-9cc29f04cd9a	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	81d9e47e-ae81-4755-a5ee-546a038fadb4	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	7727fe84-f6cc-4b31-bc00-1ecf741ad361	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921
Mirtazapine	MIRTAZAPINE	A-S Medication Solutions	67e753ad-9919-416b-9e8f-aab0fa808066	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076921 application number: ANDA076921

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	a4c012f0-50b6-42fb-9f06-a14632f23f2e	19
314111	mirtazapine 30 MG Oral Tablet	PSN	a4c012f0-50b6-42fb-9f06-a14632f23f2e	19
311726	mirtazapine 45 MG Oral Tablet	PSN	a4c012f0-50b6-42fb-9f06-a14632f23f2e	19
476809	mirtazapine 7.5 MG Oral Tablet	PSN	a4c012f0-50b6-42fb-9f06-a14632f23f2e	19
311725	mirtazapine 15 MG Oral Tablet	SCD	a4c012f0-50b6-42fb-9f06-a14632f23f2e	19
314111	mirtazapine 30 MG Oral Tablet	SCD	a4c012f0-50b6-42fb-9f06-a14632f23f2e	19
311726	mirtazapine 45 MG Oral Tablet	SCD	a4c012f0-50b6-42fb-9f06-a14632f23f2e	19
476809	mirtazapine 7.5 MG Oral Tablet	SCD	a4c012f0-50b6-42fb-9f06-a14632f23f2e	19
311725	mirtazapine 15 MG Oral Tablet	PSN	18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8	1
314111	mirtazapine 30 MG Oral Tablet	PSN	18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8	1
311726	mirtazapine 45 MG Oral Tablet	PSN	18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8	1
311725	mirtazapine 15 MG Oral Tablet	SCD	18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8	1
314111	mirtazapine 30 MG Oral Tablet	SCD	18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8	1
311726	mirtazapine 45 MG Oral Tablet	SCD	18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-031-01	65862003101	100 TABLET, FILM COATED in 1 BOTTLE (65862-031-01)	2004-10-22	0000-00-00	No	No	Current
65862-031-05	65862003105	500 TABLET, FILM COATED in 1 BOTTLE (65862-031-05)	2004-10-22	0000-00-00	No	No	Current
65862-031-19	65862003119	10000 TABLET, FILM COATED in 1 BAG (65862-031-19)	22-OCT-04				Current
65862-031-30	65862003130	30 TABLET, FILM COATED in 1 BOTTLE (65862-031-30)	2004-10-22	0000-00-00	No	No	Current
65862-031-32	65862003132	30 TABLET, FILM COATED in 1 BLISTER PACK (65862-031-32)	2004-10-22	0000-00-00	No	No	Current
65862-031-60	65862003160	60 TABLET, FILM COATED in 1 BOTTLE (65862-031-60)	2004-10-22	0000-00-00	No	No	Current
65862-031-90	65862003190	90 TABLET, FILM COATED in 1 BOTTLE (65862-031-90)	2004-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirtazapine	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-07-19	Human Prescription Drug Label	19
Mirtazapine Tablets, USP	Rebel Distributors Corp.	2010-10-06	HUMAN PRESCRIPTION DRUG LABEL	1