Piroxicam

Product NDC: 42291-953
11-digit product format: 422910953
Labeler code: 42291
Product ID: 42291-953_48c0e9da-a0ba-1b18-e063-6294a90a5957
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Piroxicam
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE
Application: ANDA210347
Marketing category: ANDA
Marketing start: 2024-08-01
Substance: PIROXICAM
Active strength: 10 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210347-001	PIROXICAM	PIROXICAM	10MG	CAPSULE / ORAL	AB		2018-01-26
A210347-002	PIROXICAM	PIROXICAM	20MG	CAPSULE / ORAL	AB		2018-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210347-001	AB
A210347-002	AB

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.

Product history page 1 of 3 · 88 observed 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
2026-10-15 13:18:30	2026-09	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A210347-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210347-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210347-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210347-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210347-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210347-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210347-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210347-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210347-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210347-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210347-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210347-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210347-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210347-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210347-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210347-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210347-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210347-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210347-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210347-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210347-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210347-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210347-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210347-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210347-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210347-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210347-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210347-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210347-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210347-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210347-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210347-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210347-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210347-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210347-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210347-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210347-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210347-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210347-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210347-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Piroxicam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIROXICAM	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
13T4O6VMAM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198107	Internal RxNorm lookup
198108	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1ea6042e-0090-df18-e063-6394a90a0a0a	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-953-01	Piroxicam	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-953-01	EA - Each	42291-953	6ecab42b-2b41-4be9-af2a-316f8ba66aeb	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-953	PIROXICAM CAPSULE [AVKARE]	1	Current NDC, 1 package rows	20240802_1ea6042e-0090-df18-e063-6394a90a0a0a.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piroxicam	PIROXICAM	PD-Rx Pharmaceuticals, Inc.	923a81d7-78e7-48e9-901d-e3ce3539aba3	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347
Piroxicam	PIROXICAM	AvKARE	1ea6042e-0090-df18-e063-6394a90a0a0a	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347 ndc (product): 42291-953
Piroxicam	PIROXICAM	Strides Pharma Science Limited	6039e036-c0aa-4249-af50-115f49ad758a	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347
Piroxicam	PIROXICAM	Direct_Rx	fa56b439-893d-003e-e053-6294a90a865b	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347
Piroxicam	PIROXICAM	Bryant Ranch Prepack	7f5ea9e8-3942-4e84-b237-c38517a97a8e	2023-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347

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	1ea6042e-0090-df18-e063-6394a90a0a0a	2
198108	piroxicam 20 MG Oral Capsule	PSN	1ea6042e-0090-df18-e063-6394a90a0a0a	2
198107	piroxicam 10 MG Oral Capsule	SCD	1ea6042e-0090-df18-e063-6394a90a0a0a	2
198108	piroxicam 20 MG Oral Capsule	SCD	1ea6042e-0090-df18-e063-6394a90a0a0a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-953-01	42291095301	100 CAPSULE in 1 BOTTLE (42291-953-01)	100 capsule	2024-08-01	No	No	Current