NDC 46708-199-10 - 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: 46708-199
Requested NDC: 46708-199-10
Package NDCs from labels: 46708-199-10, 46708-199-60, 46708-199-31
Manufacturer: Alembic Pharmaceuticals Limited
Effective date: 2023-01-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Asenapine - Alembic Pharmaceuticals Limited	Alembic Pharmaceuticals Limited	2023-01-20	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-199-10	Asenapine	10 in 1 BLISTER PACK	TABLET	10	3
46708-199-31	Asenapine	100 in 1 CARTON	TABLET	100	3
46708-199-31	Asenapine	10 in 1 BLISTER PACK	TABLET	10	3
46708-199-60	Asenapine	60 in 1 CARTON	TABLET	60	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-199	ASENAPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 4 package rows	20230121_cf587c48-9cd2-4dc5-b0e9-21783c5633a6.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mannitol	MANNITOL	B. Braun Medical Inc.	d12cc802-b538-4065-a264-f474ff3b3043	2023-08-15	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Asenapine	ASENAPINE	Alembic Pharmaceuticals Limited	cf587c48-9cd2-4dc5-b0e9-21783c5633a6	2023-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA206098 ndc (package): 46708-199-31 ndc (package): 46708-199-60 ndc (package): 46708-198-60 ndc (package): 46708-544-31 ndc (package): 46708-544-10 ndc (package): 46708-198-31 ndc (package): 46708-199-10 ndc (package): 46708-544-60 ndc (package): 46708-198-10 ndc (product): 46708-544 ndc (product): 46708-199 ndc (product): 46708-198 ndc11 (package): 46708019910 rxcui: 859981 rxcui: 1606337 rxcui: 859975 spl id: b8b5c58b-40db-4b6f-b53d-f11a842bcf28 spl set id: cf587c48-9cd2-4dc5-b0e9-21783c5633a6 unii: JKZ19V908O
Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	4c7a1b17-e73e-4417-a172-bfb03569d7ff	2021-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 859981 rxcui: 1606337 rxcui: 859975

Reported adverse events (FAERS/openFDA)#

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