FDA.reportPublic FDA data

Meloxicam

Product NDC
80425-0083
11-digit product format
804250083
Labeler code
80425
Product ID
80425-0083_2a98ebb7-ca49-d2dd-e063-6294a90ac15c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077929
Marketing category
ANDA
Marketing start
2006-07-19
Substance
MELOXICAM
Active strength
15 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL
Rxcui152695

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bdef11ce-16e2-4690-96a3-597bcf5cc738Product name120260130
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0083-1Meloxicam30 in 1 BOTTLETABLET307
80425-0083-2Meloxicam60 in 1 BOTTLETABLET607
80425-0083-3Meloxicam90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0083-1EA - Each80425-0083bfa5270b-42c1-4b44-95e2-b87a940d5c1112023-06-06
80425-0083-2EA - Each80425-00831d46ac70-1b08-4789-90af-211338a9b82112023-06-06
80425-0083-3EA - Each80425-00836589e34e-8ece-46be-909f-349c4d5a5df012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0083MELOXICAM TABLET [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_b33bf17a-3134-6f32-e053-2a95a90a261b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNb33bf17a-3134-6f32-e053-2a95a90a261b7
152695meloxicam 15 MG Oral TabletSCDb33bf17a-3134-6f32-e053-2a95a90a261b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0083-18042500830130 TABLET in 1 BOTTLE (80425-0083-1) 30 tablet2006-07-190000-00-00NoNoCurrent
80425-0083-28042500830260 TABLET in 1 BOTTLE (80425-0083-2) 60 tablet2006-07-190000-00-00NoNoCurrent
80425-0083-38042500830390 TABLET in 1 BOTTLE (80425-0083-3) 90 tablet2006-07-190000-00-00NoNoCurrent