FDA.reportPublic FDA data

Meloxicam

Product NDC
71610-583
11-digit product format
716100583
Labeler code
71610
Product ID
71610-583_2492146f-a606-419e-b4b5-83bb8d042e46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077927
Marketing category
ANDA
Marketing start
2020-02-17
Substance
MELOXICAM
Active strength
7.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meloxicam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL
Rxcui311486

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-583-15Meloxicam15 in 1 BOTTLETABLET152
71610-583-30Meloxicam30 in 1 BOTTLETABLET302
71610-583-45Meloxicam45 in 1 BOTTLETABLET452
71610-583-53Meloxicam60 in 1 BOTTLETABLET602
71610-583-60Meloxicam90 in 1 BOTTLETABLET902
71610-583-70Meloxicam120 in 1 BOTTLETABLET1202
71610-583-80Meloxicam180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-583-15EA - Each71610-58396a7a466-d25f-451c-ba1c-2006316e3d8e12022-04-06
71610-583-30EA - Each71610-583a8948bb3-3961-4596-97ca-3421d871916e12021-09-07
71610-583-45EA - Each71610-58335d3bf5e-b07c-4a1e-ad2c-f90274df596712022-04-06
71610-583-53EA - Each71610-583a3fd857f-ba03-40bb-81ca-84e5ab5cd21912022-04-06
71610-583-60EA - Each71610-5834b58edf3-1683-4539-a52d-8198d14f77ba12021-09-07
71610-583-70EA - Each71610-58303f1d37a-50a0-4edf-a51e-5e3ee1d95bdf12022-04-06
71610-583-80EA - Each71610-583a0a54d28-6d51-416e-ab07-6df95463fead12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-583MELOXICAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 7 package rows20220304_432c3937-a4fe-4c92-8452-9ed2dd2cfc9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSN432c3937-a4fe-4c92-8452-9ed2dd2cfc9a2
311486meloxicam 7.5 MG Oral TabletSCD432c3937-a4fe-4c92-8452-9ed2dd2cfc9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-583-157161005831515 TABLET in 1 BOTTLE (71610-583-15) 15 tablet2022-02-070000-00-00NoNoCurrent
71610-583-307161005833030 TABLET in 1 BOTTLE (71610-583-30) 30 tablet2021-07-150000-00-00NoNoCurrent
71610-583-457161005834545 TABLET in 1 BOTTLE (71610-583-45) 45 tablet2022-02-070000-00-00NoNoCurrent
71610-583-537161005835360 TABLET in 1 BOTTLE (71610-583-53) 60 tablet2022-02-070000-00-00NoNoCurrent
71610-583-607161005836090 TABLET in 1 BOTTLE (71610-583-60) 90 tablet2021-07-150000-00-00NoNoCurrent
71610-583-7071610058370120 TABLET in 1 BOTTLE (71610-583-70) 120 tablet2022-02-070000-00-00NoNoCurrent
71610-583-8071610058380180 TABLET in 1 BOTTLE (71610-583-80) 180 tablet2022-02-070000-00-00NoNoCurrent