FDA.reportPublic FDA data

meloxicam

Product NDC
33261-070
11-digit product format
332610070
Labeler code
33261
Product ID
33261-070_c077af4d-7cae-43da-8004-768284bda2dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077927
Marketing category
ANDA
Marketing start
2007-03-07
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
8 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
2019-12-31
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
33261-070-022020-01-31C16284748780-19d75b9d0-2ec0-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 Initial U.S. Approval: 2000
33261-070-102020-01-31C16284748780-19d75b9d0-2ec0-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 Initial U.S. Approval: 2000
33261-070-152020-01-31C16284748780-19d75b9d0-2ec0-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 Initial U.S. Approval: 2000
33261-070-202020-01-31C16284748780-19d75b9d0-2ec0-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 Initial U.S. Approval: 2000
33261-070-302020-01-31C16284748780-19d75b9d0-2ec0-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 Initial U.S. Approval: 2000
33261-070-602020-01-31C16284748780-19d75b9d0-2ec0-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 Initial U.S. Approval: 2000
33261-070-902020-01-31C16284748780-19d75b9d0-2ec0-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 Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-070-02meloxicam120 in 1 BOTTLE, PLASTICTABLET1201
33261-070-10meloxicam10 in 1 BOTTLE, PLASTICTABLET101
33261-070-15meloxicam15 in 1 BOTTLE, PLASTICTABLET151
33261-070-20meloxicam20 in 1 BOTTLE, PLASTICTABLET201
33261-070-30meloxicam30 in 1 BOTTLE, PLASTICTABLET301
33261-070-60meloxicam60 in 1 BOTTLE, PLASTICTABLET601
33261-070-90meloxicam90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-070-02EA - Each33261-0700bd9fabe-e030-4d57-872a-9f68e672883b12015-10-02
33261-070-20EA - Each33261-07031cba0c7-b92c-4d07-91f0-add2b3cbb12812015-10-02
33261-070-30EA - Each33261-0704c21d44c-fe15-414f-ad3c-978eb41d5b3412015-10-02
33261-070-60EA - Each33261-0708e8d72f8-bb8b-482b-ba42-e75df02f1cbc12015-10-02
33261-070-90EA - Each33261-07056c0e3bf-5788-4538-ac6e-0d650b7e44c612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQMELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-070MELOXICAM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 7 package rows20120929_c5e48b73-e428-41bc-973c-72003811e653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNc5e48b73-e428-41bc-973c-72003811e6531
311486meloxicam 7.5 MG Oral TabletPSNc5e48b73-e428-41bc-973c-72003811e6531
152695meloxicam 15 MG Oral TabletSCDc5e48b73-e428-41bc-973c-72003811e6531
311486meloxicam 7.5 MG Oral TabletSCDc5e48b73-e428-41bc-973c-72003811e6531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-070-0233261007002120 in 1 BOTTLE, PLASTICHistorical
33261-070-103326100701010 in 1 BOTTLE, PLASTICHistorical
33261-070-153326100701515 in 1 BOTTLE, PLASTICHistorical
33261-070-203326100702020 in 1 BOTTLE, PLASTICHistorical
33261-070-303326100703030 in 1 BOTTLE, PLASTICHistorical
33261-070-603326100706060 in 1 BOTTLE, PLASTICHistorical
33261-070-903326100709090 in 1 BOTTLE, PLASTICHistorical