Mirtazapine

Product NDC
63187-471
11-digit product format
631870471
Labeler code
63187
Product ID
63187-471_fb4bf3e5-f62b-489a-ba75-8e94513f29ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077666
Marketing category
ANDA
Marketing start
2007-08-22
Substance
MIRTAZAPINE
Active strength
45 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
A077666-001MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2007-08-22
A077666-002MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2007-08-22
A077666-003MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORALAB2007-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077666-001AB
A077666-002AB
A077666-003AB

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 · 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 UTC2026-02A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077666-002MIRTAZAPINE30MGTABLET / ORALAB2007-08-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077666-003MIRTAZAPINE45MGTABLET / ORALAB2007-08-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077666-001MIRTAZAPINE15MGTABLET / ORALAB2007-08-228072bd15b7f6…

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 UTC2026-02A077666-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077666-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077666-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077666-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077666-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077666-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077666-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077666-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077666-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077666-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077666-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077666-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077666-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077666-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077666-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077666-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077666-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077666-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077666-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077666-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077666-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077666-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077666-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077666-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077666-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077666-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077666-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077666-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077666-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077666-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077666-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077666-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077666-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077666-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077666-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077666-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077666-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077666-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077666-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077666-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE45 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311725Internal RxNorm lookup
311726Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b516a33-b164-4e4f-bc18-e9d1e591323aAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-471-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED304
63187-471-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED604
63187-471-90Mirtazapine90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-471MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20221020_3b516a33-b164-4e4f-bc18-e9d1e591323a.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINEA-S Medication Solutions44779383-3ddb-41df-8766-da5d7bef385e2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINEDirect_Rxdea8c09a-b759-1da7-e053-2a95a90a33462026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINECardinal Health 107, LLCdf06ea51-a962-49d0-a449-137e2220ce7e2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINEApotex Corp.9675333e-3064-c8cb-a4b4-6c74d9a82f172025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINECoupler LLC3eed8213-a240-fc4b-e063-6294a90a3b052025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINEMajor Pharmaceuticalsa80463be-f2d2-4074-9bd8-5e52b0832b3a2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINEAvKARE35922615-7619-3852-e063-6394a90a2e552025-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINEMcKesson Corporation dba SKY Packaging40c95daa-bbd5-48d9-97e4-c87f2c1f0fa52025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLCac976282-fb68-4db0-912a-28f075b0716c2024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLCfaba9bfd-6725-4917-ab48-24e58b397eb42023-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
MirtazapineMIRTAZAPINEProficient Rx LP3b516a33-b164-4e4f-bc18-e9d1e591323a2022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666
ndc (product): 63187-471
MirtazapineMIRTAZAPINEProficient Rx LPa2f01ffd-fd48-499b-9126-8eb9048a57222022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077666
application number: ANDA077666

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN3b516a33-b164-4e4f-bc18-e9d1e591323a4
311726mirtazapine 45 MG Oral TabletPSN3b516a33-b164-4e4f-bc18-e9d1e591323a4
311725mirtazapine 15 MG Oral TabletSCD3b516a33-b164-4e4f-bc18-e9d1e591323a4
311726mirtazapine 45 MG Oral TabletSCD3b516a33-b164-4e4f-bc18-e9d1e591323a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-471-306318704713030 TABLET, FILM COATED in 1 BOTTLE (63187-471-30) 2015-02-020000-00-00NoNoCurrent
63187-471-606318704716060 TABLET, FILM COATED in 1 BOTTLE (63187-471-60) 2015-02-020000-00-00NoNoCurrent
63187-471-906318704719090 TABLET, FILM COATED in 1 BOTTLE (63187-471-90) 2015-02-020000-00-00NoNoCurrent