FDA.reportPublic FDA data

Meloxicam

Product NDC
80425-0042
11-digit product format
804250042
Labeler code
80425
Product ID
80425-0042_2a988314-623e-2d61-e063-6294a90a3e84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077921
Marketing category
ANDA
Marketing start
2006-07-19
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
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
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
80425-0042-1Meloxicam30 in 1 BOTTLETABLET307
80425-0042-2Meloxicam60 in 1 BOTTLETABLET607
80425-0042-3Meloxicam90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0042-1EA - Each80425-004297a0a1f4-6aba-41a2-96d6-daeb4bde3e0212023-06-06
80425-0042-2EA - Each80425-0042c5fd26d3-2cb2-4f5e-853b-47edc87a838412023-06-06
80425-0042-3EA - Each80425-0042c1d07278-504c-479c-9852-2343c7726ee712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0042MELOXICAM TABLET [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_af9cf496-d505-f2ba-e053-2995a90a76cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSNaf9cf496-d505-f2ba-e053-2995a90a76cf7
311486meloxicam 7.5 MG Oral TabletSCDaf9cf496-d505-f2ba-e053-2995a90a76cf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0042-18042500420130 TABLET in 1 BOTTLE (80425-0042-1) 30 tablet2006-07-190000-00-00NoNoCurrent
80425-0042-28042500420260 TABLET in 1 BOTTLE (80425-0042-2) 60 tablet2006-07-190000-00-00NoNoCurrent
80425-0042-38042500420390 TABLET in 1 BOTTLE (80425-0042-3) 90 tablet2006-07-190000-00-00NoNoCurrent