FDA.reportPublic FDA data

Meloxicam

Product NDC
43063-395
11-digit product format
430630395
Labeler code
43063
Product ID
43063-395_509ad964-d687-66d7-e063-6294a90ab1bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077918
Marketing category
ANDA
Marketing start
2010-06-30
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-395-14Meloxicam14 in 1 BOTTLE, PLASTICTABLET1426
43063-395-20Meloxicam20 in 1 BOTTLE, PLASTICTABLET2026
43063-395-30Meloxicam30 in 1 BOTTLE, PLASTICTABLET3026
43063-395-60Meloxicam60 in 1 BOTTLE, PLASTICTABLET6026
43063-395-90Meloxicam90 in 1 BOTTLE, PLASTICTABLET9026
43063-395-95Meloxicam1000 in 1 BOTTLE, PLASTICTABLET100026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-395-14EA - Each43063-395e06ee2a2-3dca-49dc-8e7f-616c48be360012015-02-02
43063-395-20EA - Each43063-395734eaaef-5211-4fd8-8584-8901f981ceeb12016-09-02
43063-395-30EA - Each43063-39552894318-0acc-43af-bbf4-5ed170b9c78c12015-02-02
43063-395-60EA - Each43063-39524d8b76f-61bf-4678-9e22-82e53cb966c812015-02-02
43063-395-90EA - Each43063-3952e4946b8-509f-4508-a4af-688aecdc101612015-02-02
43063-395-95EA - Each43063-3958dc3fce0-4262-4112-b25d-1c0ea661175512022-01-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MeloxicamACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12
MeloxicamACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12
LactoseINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12
Magnesium StearateINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12
Povidone K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-395MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 6 package rows20250302_1ab45be4-b2b9-4374-95ab-620e0f90fb70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSN1ab45be4-b2b9-4374-95ab-620e0f90fb7026
311486meloxicam 7.5 MG Oral TabletSCD1ab45be4-b2b9-4374-95ab-620e0f90fb7026
311486meloxicam 7.5 MG Oral TabletPSN67f21bc2-c871-4ecb-b643-b2fa58d9c7191
311486meloxicam 7.5 MG Oral TabletSCD67f21bc2-c871-4ecb-b643-b2fa58d9c7191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-395-144306303951414 TABLET in 1 BOTTLE, PLASTIC (43063-395-14) 14 tablet2015-01-160000-00-00NoNoCurrent
43063-395-204306303952020 TABLET in 1 BOTTLE, PLASTIC (43063-395-20) 20 tablet2016-08-150000-00-00NoNoCurrent
43063-395-304306303953030 TABLET in 1 BOTTLE, PLASTIC (43063-395-30) 30 tablet2012-10-160000-00-00NoNoCurrent
43063-395-604306303956060 TABLET in 1 BOTTLE, PLASTIC (43063-395-60) 60 tablet2014-04-070000-00-00NoNoCurrent
43063-395-904306303959090 TABLET in 1 BOTTLE, PLASTIC (43063-395-90) 90 tablet2014-04-130000-00-00NoNoCurrent
43063-395-95430630395951000 TABLET in 1 BOTTLE, PLASTIC (43063-395-95) 1000 tablet2021-12-170000-00-00NoNoCurrent