FDA.reportPublic FDA data

Meloxicam

Product NDC
80425-0558
11-digit product format
804250558
Labeler code
80425
Product ID
80425-0558_4538a916-9d71-be91-e063-6294a90a54e1
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
2025-11-24
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
80425-0558-1Meloxicam30 in 1 BOTTLETABLET302
80425-0558-2Meloxicam60 in 1 BOTTLETABLET602
80425-0558-3Meloxicam90 in 1 BOTTLETABLET902
80425-0558-4Meloxicam120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0558-1EA - Each80425-0558af61d76d-4823-4a01-907a-b0fb37a1f69c12026-01-08
80425-0558-2EA - Each80425-055895cb0eb7-fe6e-4b59-a90f-ac6c286ea16912026-01-08
80425-0558-3EA - Each80425-05581af76c50-d821-4ebf-9d6b-2bdafc3a980a12026-01-08
80425-0558-4EA - Each80425-0558e028eb31-232c-48c9-ad4f-c13a8eec79ec12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSN445d7cbf-bd3e-a54f-e063-6294a90a67a52
311486meloxicam 7.5 MG Oral TabletSCD445d7cbf-bd3e-a54f-e063-6294a90a67a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0558-18042505580130 TABLET in 1 BOTTLE (80425-0558-1) 30 tablet2025-11-24NoNoHistorical
80425-0558-28042505580260 TABLET in 1 BOTTLE (80425-0558-2) 60 tablet2025-11-24NoNoHistorical
80425-0558-38042505580390 TABLET in 1 BOTTLE (80425-0558-3) 90 tablet2025-11-24NoNoHistorical
80425-0558-480425055804120 TABLET in 1 BOTTLE (80425-0558-4) 120 tablet2025-11-24NoNoHistorical