FDA.reportPublic FDA data

meloxicam

Product NDC
68788-8758
11-digit product format
687888758
Labeler code
68788
Product ID
68788-8758_d4d2969c-6daf-468b-802c-1b77b5b66dde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077927
Marketing category
ANDA
Marketing start
2024-10-17
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
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
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
68788-8758-0meloxicam100 in 1 BOTTLETABLET1002
68788-8758-1meloxicam15 in 1 BOTTLETABLET152
68788-8758-2meloxicam20 in 1 BOTTLETABLET202
68788-8758-3meloxicam30 in 1 BOTTLETABLET302
68788-8758-6meloxicam60 in 1 BOTTLETABLET602
68788-8758-8meloxicam28 in 1 BOTTLETABLET282
68788-8758-9meloxicam90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8758-0EA - Each68788-8758b54c1402-5f07-4e52-828f-6acb083772f212025-01-14
68788-8758-1EA - Each68788-875818d1b7c4-e04c-46ec-86ef-a97fb64c2e7f12025-01-14
68788-8758-2EA - Each68788-8758d5c982c6-6122-475f-b74d-90113aba3bcf12025-01-14
68788-8758-3EA - Each68788-87589bb4c64f-12e0-4d32-b920-1c8ae6a17e9212025-01-14
68788-8758-6EA - Each68788-8758e420dd4d-d64e-4e1f-9139-1ccdd009c0d512025-01-14
68788-8758-8EA - Each68788-8758500aa8de-b223-4465-abe8-3235647bb29312025-01-14
68788-8758-9EA - Each68788-8758737bd7ce-a446-4f22-9c93-0067b21d188712025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8758MELOXICAM TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 7 package rows20241019_c6f37980-8e09-4f2e-a768-b3d22cbe3d49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSNc6f37980-8e09-4f2e-a768-b3d22cbe3d492
311486meloxicam 7.5 MG Oral TabletSCDc6f37980-8e09-4f2e-a768-b3d22cbe3d492

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8758-068788875800100 TABLET in 1 BOTTLE (68788-8758-0) 100 tablet2024-10-17NoNoHistorical
68788-8758-16878887580115 TABLET in 1 BOTTLE (68788-8758-1) 15 tablet2024-10-17NoNoHistorical
68788-8758-26878887580220 TABLET in 1 BOTTLE (68788-8758-2) 20 tablet2024-10-17NoNoHistorical
68788-8758-36878887580330 TABLET in 1 BOTTLE (68788-8758-3) 30 tablet2024-10-17NoNoHistorical
68788-8758-66878887580660 TABLET in 1 BOTTLE (68788-8758-6) 60 tablet2024-10-17NoNoHistorical
68788-8758-86878887580828 TABLET in 1 BOTTLE (68788-8758-8) 28 tablet2024-10-17NoNoHistorical
68788-8758-96878887580990 TABLET in 1 BOTTLE (68788-8758-9) 90 tablet2024-10-17NoNoHistorical