Home NDC 67544-807 Piroxicam
Product NDC 67544-807
11-digit product format 675440807
Labeler code 67544
Product ID 67544-807_b6848545-e2e1-40d1-aa7e-e5f6100b9edd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Piroxicam
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA074131
Marketing category ANDA
Marketing start 1994-01-26
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 2019-12-31
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 2 · 84 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67544-807-20 Piroxicam 20 in 1 BOTTLE, PLASTIC CAPSULE 20 1 67544-807-30 Piroxicam 30 in 1 BOTTLE, PLASTIC CAPSULE 30 1 67544-807-60 Piroxicam 90 in 1 BOTTLE, PLASTIC CAPSULE 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PIROXICAM ACTIVE INGREDIENT 13T4O6VMAM PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 PIROXICAM ACTIVE MOIETY 13T4O6VMAM PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ETHYLENE GLYCOL MONOETHYL ETHER INACTIVE INGREDIENT IDK7C2HS09 PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-807 PIROXICAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 3 package rows 20140507_0c12b60f-ec25-4c59-8b2e-4445e600d051.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 67544-807-20 67544080720 20 in 1 BOTTLE, PLASTIC Historical 67544-807-30 67544080730 30 in 1 BOTTLE, PLASTIC Historical 67544-807-60 67544080760 90 in 1 BOTTLE, PLASTIC Historical