Mirtazapine

Product NDC
57237-012
Requested package NDC
57237-012-06
11-digit product format
572370012
Labeler code
57237
Product ID
57237-012_ed2cd1df-697f-4e63-8097-7802be5eb6bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA077376
Marketing category
ANDA
Marketing start
2005-12-08
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077376-003MIRTAZAPINE30MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077376-004MIRTAZAPINE45MGTABLET, ORALLY DISINTEGRATING / ORALAB2006-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077376-002MIRTAZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-12-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077376-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077376-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077376-002AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A051Q2099QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283406Internal RxNorm lookup
283407Internal RxNorm lookup
283485Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
73b7bbd9-7dba-4559-890f-3f8dd821e215Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-012-06Mirtazapine5 in 1 CARTONTABLET, ORALLY DISINTEGRATING514
57237-012-06Mirtazapine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-012-06EA - Each57237-0126cd6d3ec-6694-4d15-a76a-eb373a9f724212014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36AMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-012MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.]13Current NDC, Legacy NDC, 2 package rows20240201_73b7bbd9-7dba-4559-890f-3f8dd821e215.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
ndc (package): 57237-012-06
ndc (product): 57237-012
ndc11 (package): 57237001206
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283406mirtazapine 15 MG Disintegrating Oral TabletPSN73b7bbd9-7dba-4559-890f-3f8dd821e21514
283407mirtazapine 30 MG Disintegrating Oral TabletPSN73b7bbd9-7dba-4559-890f-3f8dd821e21514
283485mirtazapine 45 MG Disintegrating Oral TabletPSN73b7bbd9-7dba-4559-890f-3f8dd821e21514
283406mirtazapine 15 MG Disintegrating Oral TabletSCD73b7bbd9-7dba-4559-890f-3f8dd821e21514
283407mirtazapine 30 MG Disintegrating Oral TabletSCD73b7bbd9-7dba-4559-890f-3f8dd821e21514
283485mirtazapine 45 MG Disintegrating Oral TabletSCD73b7bbd9-7dba-4559-890f-3f8dd821e21514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-012-06572370012065 BLISTER PACK in 1 CARTON (57237-012-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2005-12-080000-00-00NoNoCurrent