FDA.reportPublic FDA data

Meloxicam

Product NDC
80425-0563
11-digit product format
804250563
Labeler code
80425
Product ID
80425-0563_453c4e1b-c69e-0681-e063-6294a90a8571
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077882
Marketing category
ANDA
Marketing start
2025-12-05
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0563-1Meloxicam30 in 1 BOTTLETABLET301
80425-0563-2Meloxicam60 in 1 BOTTLETABLET601
80425-0563-3Meloxicam90 in 1 BOTTLETABLET901
80425-0563-4Meloxicam120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0563-1EA - Each80425-05634d505ecf-7f9c-4d95-be2c-ea943bbd565a12026-01-08
80425-0563-2EA - Each80425-05633b9e3631-084b-41b7-982a-8144ce3ca9bf12026-01-08
80425-0563-3EA - Each80425-0563d3582a53-3af8-4261-a9c1-cda435ad12c112026-01-08
80425-0563-4EA - Each80425-05632cc6583f-2c69-444f-a36e-d1841a7cc43a12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSN453c5328-090e-0159-e063-6394a90a06b71
311486meloxicam 7.5 MG Oral TabletSCD453c5328-090e-0159-e063-6394a90a06b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0563-18042505630130 TABLET in 1 BOTTLE (80425-0563-1) 30 tablet2025-12-05NoNoHistorical
80425-0563-28042505630260 TABLET in 1 BOTTLE (80425-0563-2) 60 tablet2025-12-05NoNoHistorical
80425-0563-38042505630390 TABLET in 1 BOTTLE (80425-0563-3) 90 tablet2025-12-05NoNoHistorical
80425-0563-480425056304120 TABLET in 1 BOTTLE (80425-0563-4) 120 tablet2025-12-05NoNoHistorical