mirtazapine

Product NDC
0185-0212
11-digit product format
001850212
Labeler code
0185
Product ID
0185-0212_d423d909-f428-4514-9814-e0a6b94de27a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA076219
Marketing category
ANDA
Marketing start
2003-06-19
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0185-0212DDiscontinued by firm2026-08-17
excluded packagepackage0185-02120185-0212-01DDiscontinued by firm2026-08-17
excluded packagepackage0185-02120185-0212-05DDiscontinued by firm2026-08-17
excluded packagepackage0185-02120185-0212-10DDiscontinued by firm2026-08-17
excluded packagepackage0185-02120185-0212-30DDiscontinued 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 · 60 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 packagepackage0185-0212-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0212-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0212-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0212-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0212-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0212-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0212-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0212-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0212-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0212-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0212-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0212-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0212-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0212-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0212-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0212-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0212-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0212-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0212-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0212-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0212-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0212-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0212-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0212-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0212-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0212-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0212-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0212-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0212-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0212-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0212-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0212-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0212-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0212-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0212-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0212-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0212-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0212-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0212-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0212-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0212-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0212-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0212-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0212-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0212-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0212-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0212-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0212-10557ba5c1ecfa…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
A076219-001MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2003-06-19
A076219-002MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2003-06-19
A076219-003MIRTAZAPINEMIRTAZAPINE45MGTABLET / 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
A076219-001AB
A076219-002AB
A076219-003AB

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 06:07:402026-07A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076219-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076219-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076219-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-191e350fbaab3a…

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 06:07:402026-07A076219-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076219-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076219-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076219-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076219-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076219-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076219-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076219-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076219-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076219-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076219-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076219-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076219-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076219-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076219-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076219-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076219-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076219-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076219-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076219-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076219-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076219-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076219-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076219-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076219-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076219-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076219-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076219-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076219-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076219-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076219-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076219-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076219-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076219-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076219-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076219-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076219-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076219-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076219-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076219-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0212-10EA - Each0185-02121490fa09-08a7-4441-b099-ac8abf8f3ab012012-07-24
0185-0212-30EA - Each0185-021213d314c0-3ce4-4f40-b2a8-27e9aff2353312012-07-24