FDA.reportPublic FDA data

meloxicam

Product NDC
10544-925
11-digit product format
105440925
Labeler code
10544
Product ID
10544-925_d8d3e316-d33e-46e7-a7ae-02a86c39f2f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, 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
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
10544-925-142020-01-31C16284748780-19d75b9d0-7fdb-f424-e053-dadaa90a57ceThese 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
10544-925-302020-01-31C16284748780-19d75b9d0-7fdb-f424-e053-dadaa90a57ceThese 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
10544-925-14meloxicam14 in 1 BOTTLETABLET142
10544-925-30meloxicam30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-925MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 2 package rows20151201_e71623f0-a967-497f-be0d-97724f9a2263.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNe71623f0-a967-497f-be0d-97724f9a22632
152695meloxicam 15 MG Oral TabletSCDe71623f0-a967-497f-be0d-97724f9a22632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-925-141054409251414 in 1 BOTTLEHistorical
10544-925-301054409253030 in 1 BOTTLEHistorical