Mirtazapine

Product NDC
42254-087
11-digit product format
422540087
Labeler code
42254
Product ID
42254-087_2373655d-ac74-43f5-a041-9f41a5b92206
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076312
Marketing category
ANDA
Marketing start
2003-06-01
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-087IInactivated by FDA2026-08-17
excluded packagepackage42254-08742254-087-30IInactivated by FDA2026-08-17
excluded packagepackage42254-08742254-087-60IInactivated by FDA2026-08-17

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 2 · 66 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 packagepackage42254-087-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42254-087-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-087-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-087-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-087-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-087-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-087-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-087-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-087-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-087-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-087-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-087-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-087-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-087-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-087-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-087-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-087-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-087-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-087-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-087-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-087-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-087-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-087-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-087-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-087-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-087-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-087-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-087-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-087-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-087-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-087-30fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-087-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-087-3086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-087-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-087-30bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-087-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-087-308dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-087-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-087-30e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-087-60e2bbac7714bc…27bdfed8d636…

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
A076312-001MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORAL2003-06-19
A076312-002MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORAL2003-06-19
A076312-003MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORAL2003-06-19

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 06:07:402026-07A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076312-002MIRTAZAPINE30MGTABLET / ORAL2003-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076312-003MIRTAZAPINE45MGTABLET / ORAL2003-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076312-001MIRTAZAPINE15MGTABLET / ORAL2003-06-191e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5Product name320240216
a733d273-402b-1005-9891-1ac1a9c63703Product name220170724

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-087-30Mirtazapine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
42254-087-60Mirtazapine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-087-30EA - Each42254-08738bedd59-6c25-4f8e-907d-b0775daeab2712012-07-24
42254-087-60EA - Each42254-0876dbc8d09-c4da-4c88-9a36-56d714fc629012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-087MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120411_2373655d-ac74-43f5-a041-9f41a5b92206.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN2373655d-ac74-43f5-a041-9f41a5b922061
314111mirtazapine 30 MG Oral TabletPSN2373655d-ac74-43f5-a041-9f41a5b922061
311725mirtazapine 15 MG Oral TabletSCD2373655d-ac74-43f5-a041-9f41a5b922061
314111mirtazapine 30 MG Oral TabletSCD2373655d-ac74-43f5-a041-9f41a5b922061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-087-304225400873030 in 1 BOTTLE, PLASTICHistorical
42254-087-604225400876060 in 1 BOTTLE, PLASTICHistorical