FDA.reportPublic FDA data

Meloxicam

Product NDC
10544-052
11-digit product format
105440052
Labeler code
10544
Product ID
10544-052_03382d4b-f5bf-4f32-bb6b-fdd8e348cd3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077918
Marketing category
ANDA
Marketing start
2011-09-02
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-052-302020-01-31C16284748780-19d75b9cf-d091-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
10544-052-30Meloxicam30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-052-30EA - Each10544-05233b75728-528a-4390-810c-5faeff8f1f5812015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-052MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5Legacy NDC, 1 package rows20151124_55a30270-6082-452b-a081-657d51378e84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN55a30270-6082-452b-a081-657d51378e845
152695meloxicam 15 MG Oral TabletSCD55a30270-6082-452b-a081-657d51378e845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-052-301054400523030 in 1 BOTTLE, PLASTICHistorical