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 1 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
ASENAPINEASENAPINESigmapharm Laboratories, LLC3512687b-d1c7-45c4-8822-3a2ad53575a52025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 859975
unii: JKZ19V908O
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
AsenapineASENAPINEAlembic Pharmaceuticals Inc.16e1cc9f-7699-49ea-b179-acb65e1623042025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206098
ndc (package): 62332-544-60
ndc (package): 62332-199-60
ndc (package): 62332-544-10
ndc (package): 62332-198-31
ndc (package): 62332-198-60
ndc (package): 62332-199-31
ndc (package): 62332-199-10
ndc (package): 62332-198-10
ndc (package): 62332-544-31
ndc (product): 62332-198
ndc (product): 62332-199
ndc (product): 62332-544
ndc11 (package): 62332019910
rxcui: 859981
rxcui: 1606337
rxcui: 859975
spl id: d54a0a82-b197-46eb-9c1d-4e77960d6f60
spl set id: 16e1cc9f-7699-49ea-b179-acb65e162304
unii: JKZ19V908O
SAPHRISASENAPINE MALEATEAllergan, Inc.5429f134-839f-4ffc-9944-55f51238def82025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 1606337
rxcui: 859975
SECUADOASENAPINENoven Therapeutics, LLC685eaf44-5944-4f38-afba-0a4fc0b3462b2025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JKZ19V908O
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 1P9D0Z171K
AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 1606337
rxcui: 859975
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 1P9D0Z171K
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 1P9D0Z171K
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 1P9D0Z171K
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 1P9D0Z171K
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 1P9D0Z171K

Reported adverse events (FAERS/openFDA)#

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