Carvedilol

Product NDC: 10135-635
11-digit product format: 101350635
Labeler code: 10135
Product ID: 10135-635_c7cf071b-67a3-42a3-891a-1024c4e658af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA078384
Marketing category: ANDA
Marketing start: 2017-12-28
Marketing end: 0000-00-00
Substance: CARVEDILOL
Active strength: 13 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e148a93c-bfff-2735-e6c0-0739297b4596	Product name	3	20180705
32d6365f-9f0e-0782-b719-48e651893fb7	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-635-01	2021-01-29	C162847	48780-1	ba0f9c33-2039-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use CARVEDILOL T ABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLET S, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 199 5
10135-635-05	2021-01-29	C162847	48780-1	ba0f9c33-2039-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use CARVEDILOL T ABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLET S, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 199 5

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-635-01	Carvedilol	100 in 1 BOTTLE	TABLET	100		3
10135-635-05	Carvedilol	500 in 1 BOTTLE	TABLET	500		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-635-01	EA - Each	10135-635	4e32fe69-70b5-4d3b-adeb-0ba9a1d02a03	1	2018-01-12
10135-635-05	EA - Each	10135-635	21eefd88-6da6-4b03-83f2-88019a1c7def	1	2018-01-12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-635	CARVEDILOL TABLET [MARLEX PHARMACEUTICALS INC]	3	Legacy NDC, 2 package rows	20191112_b0d55eaa-7869-4d07-a92a-85ea0c598462.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K47UL67F2	CARVEDILOL	72956-09-3	CARVEDILOL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200032	carvedilol 12.5 MG Oral Tablet	PSN	b0d55eaa-7869-4d07-a92a-85ea0c598462	3
200033	carvedilol 25 MG Oral Tablet	PSN	b0d55eaa-7869-4d07-a92a-85ea0c598462	3
686924	carvedilol 3.125 MG Oral Tablet	PSN	b0d55eaa-7869-4d07-a92a-85ea0c598462	3
200031	carvedilol 6.25 MG Oral Tablet	PSN	b0d55eaa-7869-4d07-a92a-85ea0c598462	3
200032	carvedilol 12.5 MG Oral Tablet	SCD	b0d55eaa-7869-4d07-a92a-85ea0c598462	3
200033	carvedilol 25 MG Oral Tablet	SCD	b0d55eaa-7869-4d07-a92a-85ea0c598462	3
686924	carvedilol 3.125 MG Oral Tablet	SCD	b0d55eaa-7869-4d07-a92a-85ea0c598462	3
200031	carvedilol 6.25 MG Oral Tablet	SCD	b0d55eaa-7869-4d07-a92a-85ea0c598462	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-635-01	10135063501	100 in 1 BOTTLE	Historical
10135-635-05	10135063505	500 in 1 BOTTLE	Historical