Mirtazapine

Product NDC
66993-608
11-digit product format
669930608
Labeler code
66993
Product ID
66993-608_e1a19354-1c97-49ed-8ec9-bb895dbe69f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
Application
ANDA216751
Marketing category
ANDA
Marketing start
2023-09-01
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 42.

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
A216751-001MIRTAZAPINEMIRTAZAPINE7.5MGTABLET / ORALAB2023-01-18
A216751-002MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2023-01-18
A216751-003MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2023-01-18
A216751-004MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORALAB2023-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216751-001AB
A216751-002AB
A216751-003AB
A216751-004AB

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 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216751-001MIRTAZAPINE7.5MGTABLET / ORALAB2023-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216751-002MIRTAZAPINE15MGTABLET / ORALAB2023-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216751-003MIRTAZAPINE30MGTABLET / ORALAB2023-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216751-004MIRTAZAPINE45MGTABLET / ORALAB2023-01-18d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216751-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216751-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216751-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216751-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216751-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216751-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216751-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216751-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216751-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216751-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216751-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216751-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216751-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216751-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216751-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216751-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216751-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216751-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216751-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216751-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216751-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216751-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216751-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216751-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216751-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216751-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216751-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216751-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216751-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216751-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216751-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216751-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216751-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216751-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216751-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216751-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216751-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216751-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216751-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216751-004AB1d8e5a09893c0…

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311725Internal RxNorm lookup
311726Internal RxNorm lookup
314111Internal RxNorm lookup
476809Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4Available 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
66993-608-04Mirtazapine500 in 1 BOTTLETABLET, FILM COATED5004
66993-608-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-608-04EA - Each66993-60839c3f0d3-ab37-452d-8e74-2a141cbe623212024-07-12
66993-608-30EA - Each66993-60861d739d2-43d6-498d-a030-3618ea12b4db12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-608MIRTAZAPINE TABLET, FILM COATED [PRASCO LABORATORIES]4Current NDC, 2 package rows20230901_8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC20eafce1-50cd-0d9c-e063-6394a90ad6fe2024-09-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216751
application number: ANDA216751
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC1e0006b6-9405-95a7-e063-6294a90aa2772024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216751
application number: ANDA216751
MirtazapineMIRTAZAPINEPrasco Laboratories8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e42023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216751
application number: ANDA216751
ndc (product): 66993-608

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e44
314111mirtazapine 30 MG Oral TabletPSN8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e44
311726mirtazapine 45 MG Oral TabletPSN8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e44
476809mirtazapine 7.5 MG Oral TabletPSN8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e44
311725mirtazapine 15 MG Oral TabletSCD8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e44
314111mirtazapine 30 MG Oral TabletSCD8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e44
311726mirtazapine 45 MG Oral TabletSCD8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e44
476809mirtazapine 7.5 MG Oral TabletSCD8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e44
314111mirtazapine 30 MG Oral TabletPSN1e0006b6-9405-95a7-e063-6294a90aa2771
314111mirtazapine 30 MG Oral TabletSCD1e0006b6-9405-95a7-e063-6294a90aa2771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
66993-608-0466993060804500 TABLET, FILM COATED in 1 BOTTLE (66993-608-04) 2023-09-01NoNoCurrent
66993-608-306699306083030 TABLET, FILM COATED in 1 BOTTLE (66993-608-30) 2023-09-01NoNoCurrent