FDA.reportPublic FDA data

Meloxicam

Product NDC
66336-099
11-digit product format
663360099
Labeler code
66336
Product ID
66336-099_4473f13c-d981-44d8-88cf-8976a911727f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA077918
Marketing category
ANDA
Marketing start
2009-12-01
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
8 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
66336-099-942019-11-27C16284748780-19855e2a2-3e10-60a7-e053-dbdaa90a05bdThese 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 Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-099-94Meloxicam120 in 1 BOTTLE, PLASTICTABLET1202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MeloxicamACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
MeloxicamACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
LactoseINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Povidone K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-099MELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20131025_598c8808-e306-401a-9a16-e197cbfa0a0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSN598c8808-e306-401a-9a16-e197cbfa0a0d2
311486meloxicam 7.5 MG Oral TabletSCD598c8808-e306-401a-9a16-e197cbfa0a0d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-099-9466336009994120 in 1 BOTTLE, PLASTICHistorical