Piroxicam

Product NDC
63629-9148
11-digit product format
636299148
Labeler code
63629
Product ID
63629-9148_7b72edab-b564-41b9-9157-4c26def12a13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piroxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074116
Marketing category
ANDA
Marketing start
2020-02-20
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A074116-001PIROXICAM10MGCAPSULE / ORALAB1993-06-1574a2ff9319b5…
2020-12-22 03:56 UTC2020-12A074116-001PIROXICAM10MGCAPSULE / ORALAB1993-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074116-001PIROXICAM10MGCAPSULE / ORALAB1993-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074116-001PIROXICAM10MGCAPSULE / ORALAB1993-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A074116-001PIROXICAM10MGCAPSULE / ORALAB1993-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A074116-001PIROXICAM10MGCAPSULE / ORALAB1993-06-15ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074116-001AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A074116-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074116-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074116-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074116-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074116-001AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Piroxicam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIROXICAM10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
13T4O6VMAMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ee820e4-a479-4b7d-8730-101ac1f8015cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0da159c-8d1d-04a0-3db4-d969b0f40913Product name920180912

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9148-1Piroxicam100 in 1 BOTTLE, PLASTICCAPSULE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9148-1EA - Each63629-914813c064aa-ba82-4099-87e8-2a319ff7ae0912022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9148PIROXICAM CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_7ee820e4-a479-4b7d-8730-101ac1f8015c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PiroxicamPIROXICAMBryant Ranch Prepackd9684cb2-76f3-4c1b-b9e5-1f8fe55f36952024-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074116
application number: ANDA074116
PiroxicamPIROXICAMBryant Ranch Prepack7ee820e4-a479-4b7d-8730-101ac1f8015c2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074116
application number: ANDA074116
ndc (product): 63629-9148

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198107piroxicam 10 MG Oral CapsulePSN7ee820e4-a479-4b7d-8730-101ac1f8015c102
198107piroxicam 10 MG Oral CapsuleSCD7ee820e4-a479-4b7d-8730-101ac1f8015c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9148-163629914801100 CAPSULE in 1 BOTTLE, PLASTIC (63629-9148-1) 100 capsule2022-01-260000-00-00NoNoCurrent