FDA.reportPublic FDA data

MELOXICAM

Product NDC
72789-402
11-digit product format
727890402
Labeler code
72789
Product ID
72789-402_498c3694-e016-6a58-e063-6394a90a4719
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077920
Marketing category
ANDA
Marketing start
2024-05-30
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
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
MELOXICAM7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL
Rxcui152695, 311486

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
72789-402-30MELOXICAM30 in 1 BOTTLE, PLASTICTABLET3011
72789-402-60MELOXICAM60 in 1 BOTTLE, PLASTICTABLET6011
72789-402-90MELOXICAM90 in 1 BOTTLE, PLASTICTABLET9011
72789-402-95MELOXICAM1000 in 1 BOTTLE, PLASTICTABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-402-30EA - Each72789-402ab70171b-04b6-44f8-91fa-fb5cde8942c112024-09-09
72789-402-60EA - Each72789-40244d4cad0-5797-4ed9-9f78-0247e20344cc12025-02-10
72789-402-90EA - Each72789-402cee4f688-42a5-4c98-9b39-5d9b465e16eb12024-07-12
72789-402-95EA - Each72789-402824f6012-b1ed-4593-8c8d-2b068cd86af612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-402MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]9Current NDC, 4 package rows20250105_19c13159-71f1-2427-e063-6394a90ad44e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN19c13159-71f1-2427-e063-6394a90ad44e11
311486meloxicam 7.5 MG Oral TabletPSN19c13159-71f1-2427-e063-6394a90ad44e11
152695meloxicam 15 MG Oral TabletSCD19c13159-71f1-2427-e063-6394a90ad44e11
311486meloxicam 7.5 MG Oral TabletSCD19c13159-71f1-2427-e063-6394a90ad44e11
311486meloxicam 7.5 MG Oral TabletPSN2eaac8b2-d50a-a0bc-e063-6294a90a7cac1
311486meloxicam 7.5 MG Oral TabletSCD2eaac8b2-d50a-a0bc-e063-6294a90a7cac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-402-307278904023030 TABLET in 1 BOTTLE, PLASTIC (72789-402-30) 30 tablet2024-08-22NoNoHistorical
72789-402-607278904026060 TABLET in 1 BOTTLE, PLASTIC (72789-402-60) 60 tablet2025-01-03NoNoHistorical
72789-402-907278904029090 TABLET in 1 BOTTLE, PLASTIC (72789-402-90) 90 tablet2024-05-30NoNoHistorical
72789-402-95727890402951000 TABLET in 1 BOTTLE, PLASTIC (72789-402-95) 1000 tablet2024-05-30NoNoHistorical