Piroxicam

Product NDC: 29033-013
11-digit product format: 290330013
Labeler code: 29033
Product ID: 29033-013_7a032585-1f84-4c4b-a1a7-0088f1d53e8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: piroxicam
Dosage form: CAPSULE
Route: ORAL
Labeler: Nostrum Laboratories, Inc.
Application: ANDA074118
Marketing category: ANDA
Marketing start: 2020-02-20
Marketing end: 0000-00-00
Substance: PIROXICAM
Active strength: 20 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: 2021-12-31
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
29033-013-01	2026-01-29	C162847	48780-1	49896155-a300-586f-e063-e6dba90add90	These highlights do not include all the information needed to use PIROXICAM CAPSULES safely and effectively. See full prescribing information for PIROXICAM CAPSULES. PIROXICAM capsules, for oral use Initial U.S. Approval: 1982
29033-013-05	2026-01-29	C162847	48780-1	49896155-a300-586f-e063-e6dba90add90	These highlights do not include all the information needed to use PIROXICAM CAPSULES safely and effectively. See full prescribing information for PIROXICAM CAPSULES. PIROXICAM capsules, for oral use Initial U.S. Approval: 1982

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29033-013-01	Piroxicam	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		9
29033-013-05	Piroxicam	500 in 1 BOTTLE, PLASTIC	CAPSULE	500		9

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29033-013-01	EA - Each	29033-013	2ce81584-fdfd-4d11-9f80-97e3728f6664	1	2012-07-24
29033-013-05	EA - Each	29033-013	3aaac2f5-f2ff-42b5-a851-b6092192a845	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
piroxicam	ACTIVE INGREDIENT	13T4O6VMAM	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
piroxicam	ACTIVE MOIETY	13T4O6VMAM	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	7
piroxicam	ACTIVE INGREDIENT	13T4O6VMAM	PIROXICAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
piroxicam	ACTIVE INGREDIENT	13T4O6VMAM	PIROXICAM CAPSULE [DIRECT RX]	1
Piroxicam	ACTIVE MOIETY	13T4O6VMAM	PIROXICAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
PIROXICAM	ACTIVE MOIETY	13T4O6VMAM	PIROXICAM CAPSULE [DIRECT RX]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29033-013	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	9	Legacy NDC, 2 package rows	20200220_1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e.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
198108	piroxicam 20 MG Oral Capsule	PSN	0373da3a-7779-4e26-87f1-cd346018282c	105
198108	piroxicam 20 MG Oral Capsule	SCD	0373da3a-7779-4e26-87f1-cd346018282c	105
198108	piroxicam 20 MG Oral Capsule	PSN	bf53d94d-9808-44c0-a01b-a08975bc6e21	102
198108	piroxicam 20 MG Oral Capsule	SCD	bf53d94d-9808-44c0-a01b-a08975bc6e21	102
198108	piroxicam 20 MG Oral Capsule	PSN	1cd10ca2-f0a5-4b3a-bc5f-e25aba1f903c	100
198108	piroxicam 20 MG Oral Capsule	SCD	1cd10ca2-f0a5-4b3a-bc5f-e25aba1f903c	100
198107	piroxicam 10 MG Oral Capsule	PSN	1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e	9
198108	piroxicam 20 MG Oral Capsule	PSN	1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e	9
198107	piroxicam 10 MG Oral Capsule	SCD	1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e	9
198108	piroxicam 20 MG Oral Capsule	SCD	1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e	9
198108	piroxicam 20 MG Oral Capsule	PSN	c2d51858-b71f-426a-8e84-2aa13c594691	3
198108	piroxicam 20 MG Oral Capsule	SCD	c2d51858-b71f-426a-8e84-2aa13c594691	3
198107	piroxicam 10 MG Oral Capsule	PSN	53b33c73-a220-4add-ba61-b00e9e9f852b	1
198108	piroxicam 20 MG Oral Capsule	PSN	53b33c73-a220-4add-ba61-b00e9e9f852b	1
198107	piroxicam 10 MG Oral Capsule	SCD	53b33c73-a220-4add-ba61-b00e9e9f852b	1
198108	piroxicam 20 MG Oral Capsule	SCD	53b33c73-a220-4add-ba61-b00e9e9f852b	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29033-013-01	29033001301	100 CAPSULE in 1 BOTTLE, PLASTIC (29033-013-01)	100 capsule	2020-02-20	0000-00-00	No	No	Current
29033-013-05	29033001305	500 CAPSULE in 1 BOTTLE, PLASTIC (29033-013-05)	500 capsule	2020-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Piroxicam	Bryant Ranch Prepack	2024-03-11	HUMAN PRESCRIPTION DRUG LABEL	100
Piroxicam	Bryant Ranch Prepack	2023-10-25	HUMAN PRESCRIPTION DRUG LABEL	105
Piroxicam	Bryant Ranch Prepack	2023-10-25	HUMAN PRESCRIPTION DRUG LABEL	102
piroxicam	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
Piroxicam	Nostrum Laboratories, Inc.	2019-11-19	HUMAN PRESCRIPTION DRUG LABEL	9
Piroxicam	Rebel Distributors Corp	2012-01-10	HUMAN PRESCRIPTION DRUG LABEL	1