Home NDC 42291-677 Piroxicam
Product NDC 42291-677
11-digit product format 422910677
Labeler code 42291
Product ID 42291-677_ec18f190-bda4-6d26-e053-2995a90a2d66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Piroxicam
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA074131
Marketing category ANDA
Marketing start 2013-06-27
Marketing end 0000-00-00
Substance PIROXICAM
Active strength 20 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 2023-12-31
Current FDA listing Historical FDA.report record 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PIROXICAM ACTIVE INGREDIENT 13T4O6VMAM PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 PIROXICAM ACTIVE MOIETY 13T4O6VMAM PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 ETHYLENE GLYCOL MONOETHYL ETHER INACTIVE INGREDIENT IDK7C2HS09 PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 Fd&c Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 Ferric Oxide Yellow INACTIVE INGREDIENT EX438O2MRT PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 Ferrosoferric Oxide INACTIVE INGREDIENT XM0M87F357 PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PIROXICAM (PIROXICAM) CAPSULE [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-677 PIROXICAM CAPSULE [AVKARE] 11 Legacy NDC 20240111_3fa3d666-3154-23a7-1c69-915cd6f6a87c.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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-677-01 42291067701 100 CAPSULE in 1 BOTTLE (42291-677-01) 100 capsule 2013-06-27 0000-00-00 No No Current 42291-677-50 42291067750 500 CAPSULE in 1 BOTTLE (42291-677-50) 500 capsule 2013-06-27 0000-00-00 No No Current