Piroxicam
- Product NDC
- 0378-0466
- 11-digit product format
- 003780466
- Labeler code
- 0378
- Product ID
- 0378-0466_19cf4004-373f-4940-ae4b-589cb72fa137
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- piroxicam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA074116
- Marketing category
- ANDA
- Marketing start
- 2015-05-11
- Marketing end
- 2021-11-30
- 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
- 0000-00-00
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0378-0466 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0378-0466 | 0378-0466-01 | D | Discontinued by firm | 2026-08-11 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0378-0466-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0378-0466-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0378-0466-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0378-0466-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0378-0466-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0378-0466-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0378-0466-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0378-0466-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0378-0466-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0378-0466-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0378-0466-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0378-0466-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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 | 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-0466-01 | EA - Each | 0378-0466 | 4e5bc859-57ec-459e-8e44-7536f396345e | 1 | 2016-11-08 |
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.
| 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 | 074116 ANDA074116 |
| Piroxicam | PIROXICAM | Bryant Ranch Prepack | 7ee820e4-a479-4b7d-8730-101ac1f8015c | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 074116 ANDA074116 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-0466-01 | 00378046601 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-0466-01) | 100 capsule | 2015-05-11 | 2021-11-30 | No | No | Current |