FDA.reportPublic FDA data

Meloxicam

Product NDC
80425-0044
11-digit product format
804250044
Labeler code
80425
Product ID
80425-0044_2a98d0b7-6399-da12-e063-6294a90a2a7e
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
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
80425-0044-1Meloxicam30 in 1 BOTTLETABLET308
80425-0044-2Meloxicam60 in 1 BOTTLETABLET608
80425-0044-3Meloxicam90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0044-1EA - Each80425-00449a4e19d8-c9a9-43f6-8cef-78005c20d97c12023-04-07
80425-0044-2EA - Each80425-00446afc37c6-a7b6-41cc-a42a-ca25d47ed85112023-04-07
80425-0044-3EA - Each80425-0044ae7866d6-1e54-421b-81de-0fb3f11a6f7f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0044MELOXICAM TABLET [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20250101_af9cb78a-e61b-b099-e053-2a95a90a3ad8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNaf9cb78a-e61b-b099-e053-2a95a90a3ad88
152695meloxicam 15 MG Oral TabletSCDaf9cb78a-e61b-b099-e053-2a95a90a3ad88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0044-18042500440130 TABLET in 1 BOTTLE (80425-0044-1) 30 tablet2007-03-070000-00-00NoNoCurrent
80425-0044-28042500440260 TABLET in 1 BOTTLE (80425-0044-2) 60 tablet2007-03-070000-00-00NoNoCurrent
80425-0044-38042500440390 TABLET in 1 BOTTLE (80425-0044-3) 90 tablet2007-03-070000-00-00NoNoCurrent