Piroxicam

Product NDC: 29033-012
11-digit product format: 290330012
Labeler code: 29033
Product ID: 29033-012_7a032585-1f84-4c4b-a1a7-0088f1d53e8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: piroxicam
Dosage form: CAPSULE
Route: ORAL
Labeler: Nostrum Laboratories, Inc.
Application: ANDA074116
Marketing category: ANDA
Marketing start: 2020-02-20
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	29033-012		I	Inactivated by FDA		2026-08-11
excluded package	package	29033-012	29033-012-01	I	Inactivated by FDA		2026-08-11

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074116-001	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A074116-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074116-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074116-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074116-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074116-001	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0da159c-8d1d-04a0-3db4-d969b0f40913	Product name	9	20180912

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
29033-012-01	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29033-012-01	Piroxicam	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29033-012-01	EA - Each	29033-012	eea94e27-6830-4571-80a5-20b8a64fad3a	1	2012-07-24

DailyMed Socrata Ingredients#

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 PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
Piroxicam	ACTIVE MOIETY	13T4O6VMAM	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PIROXICAM CAPSULE PIROXICAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
piroxicam	ACTIVE INGREDIENT	13T4O6VMAM	PIROXICAM CAPSULE [REBEL DISTRIBUTORS CORP]	1
Piroxicam	ACTIVE MOIETY	13T4O6VMAM	PIROXICAM CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29033-012	PIROXICAM CAPSULE [NOSTRUM LABORATORIES, INC.]	9	Legacy NDC, 1 package rows	20200220_1ab9b3c7-f7b7-4cf0-8070-d0ef77232e9e.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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piroxicam	PIROXICAM	Bryant Ranch Prepack	d9684cb2-76f3-4c1b-b9e5-1f8fe55f3695	2024-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074116 application number: ANDA074116
Piroxicam	PIROXICAM	Bryant Ranch Prepack	7ee820e4-a479-4b7d-8730-101ac1f8015c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074116 application number: ANDA074116

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198107	piroxicam 10 MG Oral Capsule	PSN	7ee820e4-a479-4b7d-8730-101ac1f8015c	102
198107	piroxicam 10 MG Oral Capsule	SCD	7ee820e4-a479-4b7d-8730-101ac1f8015c	102
198107	piroxicam 10 MG Oral Capsule	PSN	d9684cb2-76f3-4c1b-b9e5-1f8fe55f3695	100
198107	piroxicam 10 MG Oral Capsule	SCD	d9684cb2-76f3-4c1b-b9e5-1f8fe55f3695	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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29033-012-01	29033001201	100 CAPSULE in 1 BOTTLE, PLASTIC (29033-012-01)	100 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	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	102
Piroxicam	Nostrum Laboratories, Inc.	2019-11-19	HUMAN PRESCRIPTION DRUG LABEL	9
PIROXICAM Capsules, USP	Golden State Medical Supply, Inc.	2018-11-07	HUMAN PRESCRIPTION DRUG LABEL	4
Piroxicam	Rebel Distributors Corp	2012-01-10	HUMAN PRESCRIPTION DRUG LABEL	1