FDA.reportPublic FDA data

Meloxicam

Product NDC
21695-077
11-digit product format
216950077
Labeler code
21695
Product ID
21695-077_145dbdd2-123e-4b06-ac03-4e08619b50f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA077927
Marketing category
ANDA
Marketing start
2006-12-20
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
21695-077-142019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg
21695-077-152019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg
21695-077-302019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg
21695-077-602019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-077-14Meloxicam14 in 1 BOTTLE, PLASTICTABLET143
21695-077-15Meloxicam15 in 1 BOTTLE, PLASTICTABLET153
21695-077-30Meloxicam30 in 1 BOTTLE, PLASTICTABLET303
21695-077-60Meloxicam60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-077-14EA - Each21695-077157e1847-8f9c-4885-85fe-05ed6e6e85db12012-07-24
21695-077-15EA - Each21695-07703e549ce-548b-4a7d-8c28-091fbd862bc812012-07-24
21695-077-30EA - Each21695-077f9752fdb-c3b9-4e8f-827f-2532886027a712012-07-24
21695-077-60EA - Each21695-0774c5836c3-80f9-442d-a9c5-6fe4f72471ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MeloxicamACTIVE INGREDIENTVG2QF83CGLMELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3
MeloxicamACTIVE MOIETYVG2QF83CGLMELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EMELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-077MELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3Legacy NDC, 4 package rows20100217_040fecdb-68cf-4967-90ce-c2130b520615.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN040fecdb-68cf-4967-90ce-c2130b5206153
311486meloxicam 7.5 MG Oral TabletPSN040fecdb-68cf-4967-90ce-c2130b5206153
152695meloxicam 15 MG Oral TabletSCD040fecdb-68cf-4967-90ce-c2130b5206153
311486meloxicam 7.5 MG Oral TabletSCD040fecdb-68cf-4967-90ce-c2130b5206153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-077-142169500771414 in 1 BOTTLE, PLASTICHistorical
21695-077-152169500771515 in 1 BOTTLE, PLASTICHistorical
21695-077-302169500773030 in 1 BOTTLE, PLASTICHistorical
21695-077-602169500776060 in 1 BOTTLE, PLASTICHistorical