FDA.reportPublic FDA data

meloxicam

Product NDC
53002-2535
11-digit product format
530022535
Labeler code
53002
Product ID
53002-2535_b6caa52f-ff5c-4ff0-b4e8-92a3cd7374a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077927
Marketing category
ANDA
Marketing start
2007-03-07
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
53002-2535-12025-01-30C16284748780-12cef2736-768d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MELOXICAM TABLETS USP. safely and effectively. See full prescribing information for MELOXICAM TABLETS USP. MELOXICAM Tablets USP, for oral use Initial U.S. Approval: 2000
53002-2535-22025-01-30C16284748780-12cef2736-768d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MELOXICAM TABLETS USP. safely and effectively. See full prescribing information for MELOXICAM TABLETS USP. MELOXICAM Tablets USP, for oral use Initial U.S. Approval: 2000
53002-2535-32025-01-30C16284748780-12cef2736-768d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MELOXICAM TABLETS USP. safely and effectively. See full prescribing information for MELOXICAM TABLETS USP. MELOXICAM Tablets USP, for oral use Initial U.S. Approval: 2000
53002-2535-52025-01-30C16284748780-12cef2736-768d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MELOXICAM TABLETS USP. safely and effectively. See full prescribing information for MELOXICAM TABLETS USP. MELOXICAM Tablets USP, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2535-1meloxicam10 in 1 BOTTLETABLET103
53002-2535-2meloxicam20 in 1 BOTTLETABLET203
53002-2535-3meloxicam30 in 1 BOTTLETABLET303
53002-2535-5meloxicam15 in 1 BOTTLETABLET153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2535MELOXICAM TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20220331_90f7991d-844f-4469-ae0b-a96f0271e966.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN90f7991d-844f-4469-ae0b-a96f0271e9663
152695meloxicam 15 MG Oral TabletSCD90f7991d-844f-4469-ae0b-a96f0271e9663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2535-15300225350110 TABLET in 1 BOTTLE (53002-2535-1) 10 tablet2021-01-010000-00-00NoNoCurrent
53002-2535-25300225350220 TABLET in 1 BOTTLE (53002-2535-2) 20 tablet2021-01-010000-00-00NoNoCurrent
53002-2535-35300225350330 TABLET in 1 BOTTLE (53002-2535-3) 30 tablet2021-01-010000-00-00NoNoCurrent
53002-2535-55300225350515 TABLET in 1 BOTTLE (53002-2535-5) 15 tablet2021-01-010000-00-00NoNoCurrent