FDA.reportPublic FDA data

meloxicam

Product NDC
50436-1124
11-digit product format
504361124
Labeler code
50436
Product ID
50436-1124_4c6010ac-d771-4a19-98f5-130efee9b671
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077927
Marketing category
ANDA
Marketing start
2007-03-07
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
8 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50436-1124-12023-01-30C16284748780-1f386c64a-2313-0266-e053-dadaa90a7c1aThese 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
50436-1124-22023-01-30C16284748780-1f386c64a-2313-0266-e053-dadaa90a7c1aThese 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
50436-1124-32023-01-30C16284748780-1f386c64a-2313-0266-e053-dadaa90a7c1aThese 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
50436-1124-1meloxicam30 in 1 BOTTLETABLET3016
50436-1124-2meloxicam60 in 1 BOTTLETABLET6016
50436-1124-3meloxicam90 in 1 BOTTLETABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-1124-1EA - Each50436-11242785e467-939f-4ad8-8753-676fba087b3c12021-10-08
50436-1124-2EA - Each50436-1124e088a5dc-6f35-4347-9ede-c83305c01daa12021-10-08
50436-1124-3EA - Each50436-1124f495b69d-76c0-4b30-983b-156be52c8cc412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1124MELOXICAM TABLET [UNIT DOSE SERVICES]16Legacy NDC, 3 package rows20210819_f772d409-e1b8-46f9-9886-14de3f031b82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNf772d409-e1b8-46f9-9886-14de3f031b8216
311486meloxicam 7.5 MG Oral TabletPSNf772d409-e1b8-46f9-9886-14de3f031b8216
152695meloxicam 15 MG Oral TabletSCDf772d409-e1b8-46f9-9886-14de3f031b8216
311486meloxicam 7.5 MG Oral TabletSCDf772d409-e1b8-46f9-9886-14de3f031b8216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-1124-15043611240130 TABLET in 1 BOTTLE (50436-1124-1) 30 tablet2021-08-180000-00-00NoNoCurrent
50436-1124-25043611240260 TABLET in 1 BOTTLE (50436-1124-2) 60 tablet2021-08-180000-00-00NoNoCurrent
50436-1124-35043611240390 TABLET in 1 BOTTLE (50436-1124-3) 90 tablet2021-08-180000-00-00NoNoCurrent