FDA.reportPublic FDA data

meloxicam

Product NDC
68071-3030
11-digit product format
680713030
Labeler code
68071
Product ID
68071-3030_45255df7-4aa8-3127-e063-6294a90ad4fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077921
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
68071-3030-92023-02-22C16284748780-1ba0f9c33-1c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
68071-3030-92023-01-30C16284748780-1ba0f9c33-1c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
68071-3030-92021-02-11C16284748780-1ba0f9c33-1c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
68071-3030-92021-01-29C16284748780-1ba0f9c33-1c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3030-5meloxicam15 in 1 BOTTLETABLET156
68071-3030-7meloxicam7 in 1 BOTTLETABLET76
68071-3030-9meloxicam90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3030MELOXICAM TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240720_87ef5a9b-2dd1-2ef9-e053-2995a90a5149.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN87ef5a9b-2dd1-2ef9-e053-2995a90a51496
152695meloxicam 15 MG Oral TabletSCD87ef5a9b-2dd1-2ef9-e053-2995a90a51496

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3030-56807130300515 TABLET in 1 BOTTLE (68071-3030-5) 15 tablet2019-05-02NoNoCurrent
68071-3030-7680713030077 TABLET in 1 BOTTLE (68071-3030-7) 7 tablet2019-05-02NoNoCurrent
68071-3030-96807130300990 TABLET in 1 BOTTLE (68071-3030-9) 90 tablet2019-05-020000-00-00NoNoCurrent