FDA.reportPublic FDA data

meloxicam

Product NDC
68382-050
11-digit product format
683820050
Labeler code
68382
Product ID
68382-050_87e6ffb9-5a3c-4579-bf50-db901cbdeca9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077921
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-050-01meloxicam100 in 1 BOTTLETABLET10024
68382-050-05meloxicam500 in 1 BOTTLETABLET50024
68382-050-16meloxicam90 in 1 BOTTLETABLET9024
68382-050-30meloxicam10 in 1 BLISTER PACKTABLET1024
68382-050-40meloxicam5000 in 1 BOTTLETABLET500024
68382-050-77meloxicam10 in 1 CARTONTABLET1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-050-01EA - Each68382-05036f945e7-0f2c-4632-bade-d09e468b62b112012-07-24
68382-050-05EA - Each68382-050f7f4f70f-b411-47fc-8a8b-9a358eb2665412012-07-24
68382-050-16EA - Each68382-0503cd62e06-d964-4a2d-bda5-ea90d9f41e1a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
POVIDONEINACTIVE INGREDIENTFZ989GH94EMELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]11
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EMELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMELOXICAM TABLET [CARILION MATERIALS MANAGEMENT]2
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [MEDVANTX, INC.]1
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [MEDVANTX, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [MEDVANTX, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMELOXICAM TABLET [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [MEDVANTX, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMELOXICAM TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-050MELOXICAM TABLET [ZYDUS PHARMACEUTICALS USA INC.]24Current NDC, Legacy NDC, 6 package rows20241003_6c015f72-5ce3-4f56-8237-776fc2165b0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSN37c030e7-f4f0-4923-847e-85325265960a106
311486meloxicam 7.5 MG Oral TabletSCD37c030e7-f4f0-4923-847e-85325265960a106
152695meloxicam 15 MG Oral TabletPSN6c015f72-5ce3-4f56-8237-776fc2165b0c24
311486meloxicam 7.5 MG Oral TabletPSN6c015f72-5ce3-4f56-8237-776fc2165b0c24
152695meloxicam 15 MG Oral TabletSCD6c015f72-5ce3-4f56-8237-776fc2165b0c24
311486meloxicam 7.5 MG Oral TabletSCD6c015f72-5ce3-4f56-8237-776fc2165b0c24
311486meloxicam 7.5 MG Oral TabletPSN7048d6cc-88a7-4743-8481-63a2005fa27a13
311486meloxicam 7.5 MG Oral TabletSCD7048d6cc-88a7-4743-8481-63a2005fa27a13
311486meloxicam 7.5 MG Oral TabletPSNaf9cf496-d505-f2ba-e053-2995a90a76cf7
311486meloxicam 7.5 MG Oral TabletPSNb0007733-b331-8202-e053-2995a90a4f697
311486meloxicam 7.5 MG Oral TabletSCDaf9cf496-d505-f2ba-e053-2995a90a76cf7
311486meloxicam 7.5 MG Oral TabletSCDb0007733-b331-8202-e053-2995a90a4f697
311486meloxicam 7.5 MG Oral TabletPSN66bc3f93-a73b-476c-83d4-7354d2e185756
311486meloxicam 7.5 MG Oral TabletSCD66bc3f93-a73b-476c-83d4-7354d2e185756
311486meloxicam 7.5 MG Oral TabletPSNb710b959-a64d-a631-e053-2995a90a21774
311486meloxicam 7.5 MG Oral TabletSCDb710b959-a64d-a631-e053-2995a90a21774
311486meloxicam 7.5 MG Oral TabletPSN0377e242-ce71-4570-afb9-ff881a575a133
311486meloxicam 7.5 MG Oral TabletSCD0377e242-ce71-4570-afb9-ff881a575a133
311486meloxicam 7.5 MG Oral TabletPSN29974b41-68b4-42cf-8835-18ae480c29522
311486meloxicam 7.5 MG Oral TabletSCD29974b41-68b4-42cf-8835-18ae480c29522
311486meloxicam 7.5 MG Oral TabletPSN966ae650-ad7d-4de1-ab06-54992408fcfd1
311486meloxicam 7.5 MG Oral TabletPSN5071e1fd-5321-42cf-e063-6294a90a0ef61
311486meloxicam 7.5 MG Oral TabletPSNe65e3c28-a40b-4daa-8fd5-29f112575b681
311486meloxicam 7.5 MG Oral TabletSCD966ae650-ad7d-4de1-ab06-54992408fcfd1
311486meloxicam 7.5 MG Oral TabletSCD5071e1fd-5321-42cf-e063-6294a90a0ef61
311486meloxicam 7.5 MG Oral TabletSCDe65e3c28-a40b-4daa-8fd5-29f112575b681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-050-0168382005001100 TABLET in 1 BOTTLE (68382-050-01) 100 tablet2006-07-190000-00-00NoNoCurrent
68382-050-0568382005005500 TABLET in 1 BOTTLE (68382-050-05) 500 tablet2006-07-190000-00-00NoNoCurrent
68382-050-166838200501690 TABLET in 1 BOTTLE (68382-050-16) 90 tablet2006-07-190000-00-00NoNoCurrent
68382-050-306838200503010 in 1 BLISTER PACKHistorical
68382-050-40683820050405000 TABLET in 1 BOTTLE (68382-050-40) 5000 tablet2006-07-190000-00-00NoNoCurrent
68382-050-776838200507710 BLISTER PACK in 1 CARTON (68382-050-77) / 10 TABLET in 1 BLISTER PACK (68382-050-30) 10 blister pack2006-07-190000-00-00NoNoCurrent