FDA.reportPublic FDA data

Meloxicam

Product NDC
54458-964
11-digit product format
544580964
Labeler code
54458
Product ID
54458-964_f4f97161-067c-4102-82a0-cd011d500583
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA077921
Marketing category
ANDA
Marketing start
2008-12-01
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
15 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
2020-12-31
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
54458-964-102023-01-30C16284748780-1f386c649-dd36-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MELOXICAM TABLETS safety and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
54458-964-162023-01-30C16284748780-1f386c649-dd36-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MELOXICAM TABLETS safety 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
54458-964-10Meloxicam30 in 1 BLISTER PACKTABLET3022
54458-964-16Meloxicam30 in 1 BOTTLETABLET3022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-964-10EA - Each54458-96463f30728-d1b4-431b-89b6-78b66908d15e12012-07-24
54458-964-16EA - Each54458-9647f774ae9-f9bf-413b-877d-048dd6a07ee812017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKMELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15
POVIDONESINACTIVE INGREDIENTFZ989GH94EMELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-964MELOXICAM TABLET [INTERNATIONAL LABORATORIES, LLC]22Legacy NDC, 2 package rows20191219_06623222-188c-4ab1-976a-4cdb2037a709.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN06623222-188c-4ab1-976a-4cdb2037a70922
311486meloxicam 7.5 MG Oral TabletPSN06623222-188c-4ab1-976a-4cdb2037a70922
152695meloxicam 15 MG Oral TabletSCD06623222-188c-4ab1-976a-4cdb2037a70922
311486meloxicam 7.5 MG Oral TabletSCD06623222-188c-4ab1-976a-4cdb2037a70922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54458-964-105445809641030 TABLET in 1 BLISTER PACK (54458-964-10) 30 tablet2008-12-010000-00-00NoNoCurrent
54458-964-165445809641630 TABLET in 1 BOTTLE (54458-964-16) 30 tablet2017-05-220000-00-00NoNoCurrent