FDA.reportPublic FDA data

Meloxicam

Product NDC
80425-0041
11-digit product format
804250041
Labeler code
80425
Product ID
80425-0041_4ceff67f-3d7e-b947-e063-6394a90a83e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077927
Marketing category
ANDA
Marketing start
2007-03-07
Substance
MELOXICAM
Active strength
7.5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meloxicam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL
Rxcui311486

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
80425-0041-1Meloxicam30 in 1 BOTTLETABLET309
80425-0041-2Meloxicam60 in 1 BOTTLETABLET609
80425-0041-3Meloxicam90 in 1 BOTTLETABLET909
80425-0041-4Meloxicam6 in 1 BOTTLETABLET69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0041-1EA - Each80425-0041976a2e18-f918-450a-a711-aaa83b01ac4812023-04-07
80425-0041-2EA - Each80425-00417421f63a-621e-4bd7-ae5c-0734afdc147a12023-04-07
80425-0041-3EA - Each80425-004107712d30-38f4-42fe-a5ac-05b9301c191412023-04-07
80425-0041-4EA - Each80425-004127bedd73-2fc0-4f21-a033-6c378c798c5012026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0041MELOXICAM TABLET [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20250101_af9ce58c-3cd7-769f-e053-2a95a90a5385.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSNaf9ce58c-3cd7-769f-e053-2a95a90a53859
311486meloxicam 7.5 MG Oral TabletSCDaf9ce58c-3cd7-769f-e053-2a95a90a53859

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0041-18042500410130 TABLET in 1 BOTTLE (80425-0041-1) 30 tablet2007-03-070000-00-00NoNoCurrent
80425-0041-28042500410260 TABLET in 1 BOTTLE (80425-0041-2) 60 tablet2007-03-070000-00-00NoNoCurrent
80425-0041-38042500410390 TABLET in 1 BOTTLE (80425-0041-3) 90 tablet2007-03-070000-00-00NoNoCurrent
80425-0041-4804250041046 TABLET in 1 BOTTLE (80425-0041-4) 6 tablet2007-03-07NoNoCurrent