Piroxicam

Product NDC: 42543-114
11-digit product format: 425430114
Labeler code: 42543
Product ID: 42543-114_bceebd41-54dd-4a1e-b250-f1e460bb903d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Piroxicam
Dosage form: CAPSULE
Route: ORAL
Labeler: Vensun Pharmaceuticals, Inc.
Application: ANDA206136
Marketing category: ANDA
Marketing start: 2017-09-28
Marketing end: 0000-00-00
Substance: PIROXICAM
Active strength: 10 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [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
a0da159c-8d1d-04a0-3db4-d969b0f40913	Product name	9	20180912

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42543-114-01	2025-01-30	C162847	48780-1	2cef2736-b0a8-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use PIROXICAM capsules, USP safely and effectively. See full prescribing information for PIROXICAM capsules, USP. PIROXICAM capsules, USP, for oral use Initial U.S. Approval: 1982

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42543-114-01	Piroxicam	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		8

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-114-01	EA - Each	42543-114	307e19fa-7734-470e-8920-26bb4f076cc7	1	2018-02-20

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-114	PIROXICAM CAPSULE [VENSUN PHARMACEUTICALS, INC.]	8	Legacy NDC, 1 package rows	20190702_18120467-c024-4d5a-8fcf-105e72a3e671.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
13T4O6VMAM	PIROXICAM	36322-90-4	PIROXICAM

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198107	piroxicam 10 MG Oral Capsule	PSN	18120467-c024-4d5a-8fcf-105e72a3e671	8
198108	piroxicam 20 MG Oral Capsule	PSN	18120467-c024-4d5a-8fcf-105e72a3e671	8
198107	piroxicam 10 MG Oral Capsule	SCD	18120467-c024-4d5a-8fcf-105e72a3e671	8
198108	piroxicam 20 MG Oral Capsule	SCD	18120467-c024-4d5a-8fcf-105e72a3e671	8

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42543-114-01	42543011401	100 CAPSULE in 1 BOTTLE, PLASTIC (42543-114-01)	100 capsule	2017-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Piroxicam	Vensun Pharmaceuticals, Inc. \| Pharmaceutics International, Inc. (Pii)	2019-05-31	HUMAN PRESCRIPTION DRUG LABEL	8