FDA.reportPublic FDA data

MELOXICAM

Product NDC
68071-2184
11-digit product format
680712184
Labeler code
68071
Product ID
68071-2184_200c6f9e-247b-56e1-e063-6394a90a000d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA077929
Marketing category
ANDA
Marketing start
2006-07-19
Substance
MELOXICAM
Active strength
15 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
MELOXICAM15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL
Rxcui152695

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2184-32023-06-19C16284748780-19d75b9d0-f4d2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. Initial U.S. Approval: 2000
68071-2184-32023-01-30C16284748780-19d75b9d0-f4d2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. Initial U.S. Approval: 2000
68071-2184-32020-10-12C16284748780-19d75b9d0-f4d2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. Initial U.S. Approval: 2000
68071-2184-32020-01-31C16284748780-19d75b9d0-f4d2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2184-3MELOXICAM30 in 1 BOTTLETABLET306
68071-2184-5MELOXICAM15 in 1 BOTTLETABLET156
68071-2184-9MELOXICAM90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2184MELOXICAM TABLET [NUCARE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20240820_43ca4ab6-7d52-2954-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN43ca4ab6-7d52-2954-e054-00144ff88e886
152695meloxicam 15 MG Oral TabletSCD43ca4ab6-7d52-2954-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2184-36807121840330 TABLET in 1 BOTTLE (68071-2184-3) 30 tablet2016-12-160000-00-00NoNoCurrent
68071-2184-56807121840515 TABLET in 1 BOTTLE (68071-2184-5) 15 tablet2023-06-16NoNoCurrent
68071-2184-96807121840990 TABLET in 1 BOTTLE (68071-2184-9) 90 tablet2023-06-16NoNoCurrent