FDA.reportPublic FDA data

Meloxicam

Product NDC
21695-076
11-digit product format
216950076
Labeler code
21695
Product ID
21695-076_145dbdd2-123e-4b06-ac03-4e08619b50f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Labeler
Rebel Distributors Corp.
Application
ANDA077927
Marketing category
ANDA
Marketing start
2006-12-20
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
21695-076-142019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg
21695-076-152019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg
21695-076-302019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg
21695-076-602019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg
21695-076-902019-09-24C16284748780-1934fe258-4a13-48b1-e053-8cdaa90a720aMeloxicam Tablets 7.5 mg and 15 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-076-14Meloxicam14 in 1 BOTTLE, PLASTICTABLET143
21695-076-15Meloxicam15 in 1 BOTTLE, PLASTICTABLET153
21695-076-30Meloxicam30 in 1 BOTTLE, PLASTICTABLET303
21695-076-60Meloxicam60 in 1 BOTTLE, PLASTICTABLET603
21695-076-90Meloxicam90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-076-14EA - Each21695-076ae684c5d-24b5-4a78-8a25-12f6f9a86a0812012-07-24
21695-076-15EA - Each21695-076f18b335e-4cf1-459e-b129-34e82fadd4ac12012-07-24
21695-076-30EA - Each21695-07663664121-6c62-4532-ae5e-bb8bcf7863b512012-07-24
21695-076-60EA - Each21695-0761ae57949-f15c-4552-b646-3edb96f2f4db12012-07-24
21695-076-90EA - Each21695-07659fd3df5-0aa9-478a-b3dc-90acf5e9364412012-07-24

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
21695-076MELOXICAM (MELOXICAM) TABLET MELOXICAM (MELOXICAM) TABLET [REBEL DISTRIBUTORS CORP.]3Legacy NDC, 5 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
21695-076-142169500761414 in 1 BOTTLE, PLASTICHistorical
21695-076-152169500761515 in 1 BOTTLE, PLASTICHistorical
21695-076-302169500763030 in 1 BOTTLE, PLASTICHistorical
21695-076-602169500766060 in 1 BOTTLE, PLASTICHistorical
21695-076-902169500769090 in 1 BOTTLE, PLASTICHistorical