Home NDC 52959-398 Piroxicam
Product NDC 52959-398
11-digit product format 529590398
Labeler code 52959
Product ID 52959-398_bd59acb2-4996-4167-a558-00c59a0653d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Piroxicam
Dosage form CAPSULE
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA074131
Marketing category ANDA
Marketing start 2012-04-16
Marketing end 0000-00-00
Substance PIROXICAM
Active strength 10 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 3 · 154 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A074131-001 PIROXICAM PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 A074131-002 PIROXICAM PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074131-001 PIROXICAM 10MG CAPSULE / ORAL AB 1992-12-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074131-002 PIROXICAM 20MG CAPSULE / ORAL AB 1992-12-11 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PIROXICAM ACTIVE INGREDIENT 13T4O6VMAM PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 PIROXICAM ACTIVE MOIETY 13T4O6VMAM PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 ETHYLENE GLYCOL MONOETHYL ETHER INACTIVE INGREDIENT IDK7C2HS09 PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-398 PIROXICAM CAPSULE [H.J. HARKINS COMPANY, INC.] 2 Legacy NDC, 6 package rows 20120430_4314317f-436e-4c70-b418-220a4c984727.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Piroxicam PIROXICAM Teva Pharmaceuticals USA, Inc. f1123fe1-b79c-430b-8548-08cd6e518482 2025-01-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074131 application number: ANDA074131
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-398-00 52959039800 100 in 1 BOTTLE Historical 52959-398-10 52959039810 10 in 1 BOTTLE Historical 52959-398-20 52959039820 20 in 1 BOTTLE Historical 52959-398-21 52959039821 21 in 1 BOTTLE Historical 52959-398-30 52959039830 30 in 1 BOTTLE Historical 52959-398-60 52959039860 60 in 1 BOTTLE Historical