FDA.reportPublic FDA data

NDC 63629-2368-01 - Mirtazapine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-2368
Requested NDC
63629-2368-01
Package NDCs from labels
63629-2368-1, 63629-2368-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-11-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mirtazapine - Bryant Ranch PrepackBryant Ranch Prepack2024-11-27HUMAN PRESCRIPTION DRUG LABEL
Mirtazapine - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2023-06-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2368-1Mirtazapine30 in 1 BOTTLETABLET30106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2368MIRTAZAPINE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20241128_3bb242b0-42ed-471a-b3c4-5ded1e292e80.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2368-1EA - Each63629-2368ced23ccb-2600-4a72-a772-acd09f2d68c212021-04-08

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 3 of 109 · 2,164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
MirtazapineMIRTAZAPINEBryant Ranch Prepack577c3ceb-316b-4c93-9b0c-0a4b1b4773e92026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076541
rxcui: 314111
unii: A051Q2099Q
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MirtazapineMIRTAZAPINEREMEDYREPACK INC.9135e7db-cba4-4150-a69c-fdf2a347a7852026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
unii: A051Q2099Q
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.c22c4325-4f1a-4d12-8039-d3b1263fa3ad2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
unii: A051Q2099Q
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.ac3716fd-6971-4a70-ae7b-9f5117f3d8802026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314111
unii: A051Q2099Q
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.2a0689ae-5650-42d1-ac9d-56dd2b4677272026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311726
unii: A051Q2099Q
MirtazapineMIRTAZAPINECardinal Health 107, LLC7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311725
unii: A051Q2099Q
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
MirtazapineMIRTAZAPINEREMEDYREPACK INC.aae4c58a-5cbd-45ef-b0f9-32bf28204f152026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314111
unii: A051Q2099Q
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
MirtazapineMIRTAZAPINEAmerican Health Packaging82a615a0-e74a-49cb-9a57-ffbb3df604d52026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311726
rxcui: 311725
rxcui: 314111
unii: A051Q2099Q

Reported adverse events (FAERS/openFDA)#

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