FDA.reportPublic FDA data

NDC 62332-199-10 - Asenapine

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
62332-199
Requested NDC
62332-199-10
Package NDCs from labels
62332-199-10, 62332-199-60, 62332-199-31
Manufacturer
Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited
Effective date
2025-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Asenapine - Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals LimitedAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2025-02-25Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-199-10Asenapine10 in 1 BLISTER PACKTABLET1016
62332-199-31Asenapine100 in 1 CARTONTABLET10016
62332-199-31Asenapine10 in 1 BLISTER PACKTABLET1016
62332-199-60Asenapine60 in 1 CARTONTABLET6016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-199ASENAPINE TABLET [ALEMBIC PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 4 package rows20250427_16e1cc9f-7699-49ea-b179-acb65e162304.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-199-10EA - Each62332-199e443fb7e-707e-4b23-9277-7d974e66ea3312022-03-09
62332-199-31EA - Each62332-1995a33e162-4428-4cf7-acd9-c676943686f512021-01-08
62332-199-60EA - Each62332-199a9410d63-5754-4755-b80d-8f8860705b3812021-01-08

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
AsenapineASENAPINEAlembic Pharmaceuticals Limitedcf587c48-9cd2-4dc5-b0e9-21783c5633a62023-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206098
rxcui: 859981
rxcui: 1606337
rxcui: 859975
unii: JKZ19V908O
AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITED4c7a1b17-e73e-4417-a172-bfb03569d7ff2021-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 1606337
rxcui: 859975

Reported adverse events (FAERS/openFDA)#

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