Mirtazapine

Product NDC
63629-5086
11-digit product format
636295086
Labeler code
63629
Product ID
63629-5086_3bde04e7-1aea-4890-8c98-ea1d26434c20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077376
Marketing category
ANDA
Marketing start
2005-12-08
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-5086DDiscontinued by firm2026-08-17
excluded packagepackage63629-508663629-5086-1DDiscontinued 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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-5086-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-5086-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-5086-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-5086-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A077376-002MIRTAZAPINEMIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08
A077376-003MIRTAZAPINEMIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08
A077376-004MIRTAZAPINEMIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077376-002AB
A077376-003AB
A077376-004AB

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 06:07:402026-07A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-081e350fbaab3a…

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 06:07:402026-07A077376-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077376-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077376-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077376-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077376-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077376-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077376-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077376-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077376-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077376-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077376-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077376-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077376-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077376-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077376-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077376-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077376-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077376-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077376-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077376-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077376-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077376-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077376-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077376-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077376-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077376-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077376-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077376-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077376-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077376-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077376-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077376-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077376-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077376-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077376-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077376-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077376-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077376-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077376-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077376-002AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5Product name320240216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a733d273-402b-1005-9891-1ac1a9c63703Product name220170724
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5086MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1006Legacy NDC20240518_3bde04e7-1aea-4890-8c98-ea1d26434c20.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINEBryant Ranch Prepackf86f1175-806f-4416-af86-b1e28def82442025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077376
application number: ANDA077376
MirtazapineMIRTAZAPINERising Pharma Holdings, Inc.73b7bbd9-7dba-4559-890f-3f8dd821e2152025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077376
application number: ANDA077376
MirtazapineMIRTAZAPINECardinal Health 107, LLC5127517f-b8d0-4af1-8a2f-5225719600bc2025-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077376
application number: ANDA077376
MirtazapineMIRTAZAPINEAurobindo Pharma Limited3a8a4490-9243-4201-944d-cea27d3d69f52025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077376
application number: ANDA077376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5086-16362950860130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-5086-1) 2013-09-040000-00-00NoNoCurrent