FDA.reportPublic FDA data

meloxicam

Product NDC
51655-577
11-digit product format
516550577
Labeler code
51655
Product ID
51655-577_494e4f77-c354-a2ef-e063-6294a90a173e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077927
Marketing category
ANDA
Marketing start
2014-04-02
Substance
MELOXICAM
Active strength
15 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
meloxicam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL
Rxcui152695

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
51655-577-262023-04-06C16284748780-19d75b9d0-7462-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS. safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
51655-577-522023-04-06C16284748780-19d75b9d0-7462-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS. safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
51655-577-262023-01-30C16284748780-19d75b9d0-7462-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS. safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
51655-577-522023-01-30C16284748780-19d75b9d0-7462-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS. safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
51655-577-262021-10-14C16284748780-19d75b9d0-7462-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS. safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
51655-577-522021-10-14C16284748780-19d75b9d0-7462-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS. safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
51655-577-262020-01-31C16284748780-19d75b9d0-7462-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS. safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000
51655-577-522020-01-31C16284748780-19d75b9d0-7462-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MELOXICAM TABLETS. safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-577-26meloxicam90 in 1 BOTTLE, DISPENSINGTABLET906
51655-577-52meloxicam30 in 1 BOTTLE, DISPENSINGTABLET306
51655-577-84meloxicam14 in 1 BOTTLE, PLASTICTABLET146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-577-26EA - Each51655-5772662f1fa-ebf4-4039-8f05-d6c92c3b681612021-11-09
51655-577-52EA - Each51655-577aebcd23d-f070-4dd5-bf62-e209ecc04d3e12021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [NORTHWIND PHARMACEUTICALS]2
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-577MELOXICAM TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 3 package rows20241225_3ce43f4a-c525-4ce1-b328-514b3912e305.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN3ce43f4a-c525-4ce1-b328-514b3912e3056
152695meloxicam 15 MG Oral TabletSCD3ce43f4a-c525-4ce1-b328-514b3912e3056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-577-265165505772690 TABLET in 1 BOTTLE, DISPENSING (51655-577-26) 90 tablet2014-04-020000-00-00NoNoCurrent
51655-577-525165505775230 TABLET in 1 BOTTLE, DISPENSING (51655-577-52) 30 tablet2014-04-020000-00-00NoNoCurrent
51655-577-845165505778414 TABLET in 1 BOTTLE, PLASTIC (51655-577-84) 14 tablet2022-07-12NoNoCurrent