Mirtazapine

Product NDC
63187-207
11-digit product format
631870207
Labeler code
63187
Product ID
63187-207_f5000a4c-d635-4a30-88af-23fe92094293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076119
Marketing category
ANDA
Marketing start
2003-01-29
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-207DDiscontinued by firm2026-08-17
excluded packagepackage63187-20763187-207-30DDiscontinued by firm2026-08-17
excluded packagepackage63187-20763187-207-60DDiscontinued by firm2026-08-17
excluded packagepackage63187-20763187-207-90DDiscontinued by firm2026-08-17

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-207-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-207-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-207-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-207-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-207-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-207-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63187-207-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63187-207-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63187-207-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63187-207-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63187-207-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63187-207-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63187-207-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63187-207-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63187-207-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63187-207-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63187-207-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63187-207-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63187-207-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63187-207-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63187-207-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63187-207-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63187-207-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63187-207-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63187-207-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63187-207-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63187-207-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63187-207-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63187-207-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63187-207-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63187-207-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63187-207-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63187-207-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63187-207-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63187-207-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63187-207-60557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076119-001MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2003-01-24
A076119-002MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2003-01-24
A076119-003MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORALAB2003-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076119-001AB
A076119-002AB
A076119-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076119-002MIRTAZAPINE30MGTABLET / ORALAB2003-01-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076119-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076119-001MIRTAZAPINE15MGTABLET / ORALAB2003-01-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076119-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076119-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076119-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076119-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076119-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076119-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076119-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076119-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076119-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076119-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076119-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076119-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076119-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076119-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076119-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076119-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076119-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076119-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076119-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076119-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076119-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076119-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076119-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076119-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076119-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076119-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076119-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076119-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076119-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076119-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076119-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076119-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076119-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076119-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076119-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076119-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076119-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076119-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076119-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076119-001AB11e350fbaab3a…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3