FDA.reportPublic FDA data

Meloxicam

Product NDC
68180-501
11-digit product format
681800501
Labeler code
68180
Product ID
68180-501_ea7f4d30-9a36-44fa-bc78-f8e64ae91651
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA077944
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
Rxcui152695, 311486

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
68180-501-01Meloxicam100 in 1 BOTTLETABLET10015
68180-501-03Meloxicam1000 in 1 BOTTLETABLET100015
68180-501-09Meloxicam90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-501-01EA - Each68180-501af8d040c-864e-4679-8179-cc850a7bfff812012-07-24
68180-501-03EA - Each68180-501602651c8-7896-41bb-9f39-e1bcd657958a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EMELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]7
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-501MELOXICAM TABLET [LUPIN PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 3 package rows20240815_06a401f0-4380-4081-86ed-a309a25abf6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN06a401f0-4380-4081-86ed-a309a25abf6b15
311486meloxicam 7.5 MG Oral TabletPSN06a401f0-4380-4081-86ed-a309a25abf6b15
152695meloxicam 15 MG Oral TabletSCD06a401f0-4380-4081-86ed-a309a25abf6b15
311486meloxicam 7.5 MG Oral TabletSCD06a401f0-4380-4081-86ed-a309a25abf6b15
311486meloxicam 7.5 MG Oral TabletPSN0a5ccef7-edba-4498-bec2-6b25d551e04b1
311486meloxicam 7.5 MG Oral TabletSCD0a5ccef7-edba-4498-bec2-6b25d551e04b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-501-0168180050101100 TABLET in 1 BOTTLE (68180-501-01) 100 tablet2006-07-190000-00-00NoNoCurrent
68180-501-03681800501031000 TABLET in 1 BOTTLE (68180-501-03) 1000 tablet2006-07-190000-00-00NoNoCurrent
68180-501-096818005010990 in 1 BOTTLEHistorical