Mirtazapine

Product NDC
71610-115
11-digit product format
716100115
Labeler code
71610
Product ID
71610-115_741ce88a-0753-461f-b456-4d026b540985
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Substance
MIRTAZAPINE
Active strength
15 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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076921-001MIRTAZAPINEMIRTAZAPINE7.5MGTABLET / ORALAB2004-10-22
A076921-002MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2004-10-22
A076921-003MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2004-10-22
A076921-004MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORALAB2004-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076921-001AB
A076921-002AB
A076921-003AB
A076921-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-2284e616aacf4f…
2026-08-18 06:07:402026-07A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076921-001MIRTAZAPINE7.5MGTABLET / ORALAB2004-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076921-002MIRTAZAPINE15MGTABLET / ORALAB2004-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076921-003MIRTAZAPINE30MGTABLET / ORALAB2004-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076921-004MIRTAZAPINE45MGTABLET / ORALAB2004-10-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076921-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076921-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076921-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076921-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A076921-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076921-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076921-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076921-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076921-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076921-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076921-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076921-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076921-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076921-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076921-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076921-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076921-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076921-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076921-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076921-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076921-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076921-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076921-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076921-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076921-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076921-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076921-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076921-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076921-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076921-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076921-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076921-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076921-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076921-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076921-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076921-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076921-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076921-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076921-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076921-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE15 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bda4994-cdf5-47b4-aebc-7297347334e9Available 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
71610-115-15Mirtazapine15 in 1 BOTTLETABLET, FILM COATED151
71610-115-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED301
71610-115-60Mirtazapine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-115-15EA - Each71610-1155e0401f9-5b6c-45bd-af9c-699a2cbdf19712018-10-11
71610-115-30EA - Each71610-115f123fa15-10cf-470a-a005-ea8f2a5ac3c512018-10-11
71610-115-60EA - Each71610-1156347ebd6-fc62-48a2-888e-31674ae8729b12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-115MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20180829_3bda4994-cdf5-47b4-aebc-7297347334e9.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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINENuCare Pharmaceuticals,Inc.d6fbe837-988a-7c75-e053-2995a90a599a2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINENuCare Pharmaceuticals,Inc.e38c96d4-ea33-3f1a-e053-2a95a90a09032026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINECoupler LLC598e441a-aa1a-6fb3-e063-6394a90a14aa2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINERedpharm Drug58bea4d8-084f-4c30-e063-6394a90a35cb2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEREMEDYREPACK INC.10ea9d83-19c3-4f3b-a1cc-cfc48b42507f2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEREMEDYREPACK INC.9135e7db-cba4-4150-a69c-fdf2a347a7852026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.c22c4325-4f1a-4d12-8039-d3b1263fa3ad2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.ac3716fd-6971-4a70-ae7b-9f5117f3d8802026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.2a0689ae-5650-42d1-ac9d-56dd2b4677272026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEREMEDYREPACK INC.aae4c58a-5cbd-45ef-b0f9-32bf28204f152026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEAmerican Health Packaging82a615a0-e74a-49cb-9a57-ffbb3df604d52026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEUnit Dose Solutions, Inc.5539fe37-546b-40a8-e063-6394a90ace1b2026-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINECoupler LLC538679a1-d474-8e1c-e063-6394a90a15d72026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINECoupler LLC53311d08-9dfa-7bb1-e063-6394a90a66562026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINECoupler LLC51269807-2b5a-e7aa-e063-6394a90ab6572026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINECoupler LLC50718832-88fb-dec1-e063-6294a90ae4682026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEA-S Medication Solutions552e2261-53db-4a27-b277-f7b62c3ea2ed2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEREMEDYREPACK INC.1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEREMEDYREPACK INC.f54718d1-3ef7-4472-9e97-90e5fd30db4d2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921
MirtazapineMIRTAZAPINEBryant Ranch Prepack6b6e946c-54b5-40e3-918f-9cc29f04cd9a2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076921
application number: ANDA076921

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN3bda4994-cdf5-47b4-aebc-7297347334e91
311725mirtazapine 15 MG Oral TabletSCD3bda4994-cdf5-47b4-aebc-7297347334e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-115-157161001151515 TABLET, FILM COATED in 1 BOTTLE (71610-115-15) 2018-08-090000-00-00NoNoCurrent
71610-115-307161001153030 TABLET, FILM COATED in 1 BOTTLE (71610-115-30) 2018-08-090000-00-00NoNoCurrent
71610-115-607161001156090 TABLET, FILM COATED in 1 BOTTLE (71610-115-60) 2018-08-090000-00-00NoNoCurrent